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Regulatory Affairs

Global Understanding of Local Regulations

At Bioviser, we excel at assessing the emerging regulatory trends to meet the legal obligations and directives of global regulations for healthcare. Our unique approach captures and analyses regulations globally.

Bioviser’s regulatory affairs experts offer a robust strategy for your business to obtain and maintain regulatory licenses.

Our team assists you in the regulatory strategy right from concept to commercialization of your product as we understand that regulatory functions are critical throughout the entire lifecycle of a healthcare product.

Bioviser can be a trusted partner for all your regulatory compliance needs.

Control Safety and Protect Public Health

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HOW WE HELP

Backed by Bioviser’s Seasoned Experts

The Bioviser team collaborates across different functions of your business to create a significant impact. With decades of knowledge and experience under their belt, our experts understand the technical details of a product. We view the available information through a critical lens to understand the product profile and see it in the context of patient needs.

We have a deep understanding of local as well as global regulations. Our experts keep abreast of current legislation, regulatory intelligence, and relevant guidelines including USFDA, MHRA, EMA and PMDA. We deliver great results regardless of geographies.

Regulatory Affairs Deliverables

  • IDMP Consulting
  • Regulatory post market compliance support
  • IVDR consulting
  • Strategic support for study design
  • Regulatory intelligence
  • Medical device consulting
  • Handling queries from health authorities
  • Clinical overviews (eCTD Module 2.5)
  • Clinical summaries (eCTD Module 2.7)
  • Clinical study report (eCTD Module 5)
  • Strategic labelling, Publishing
  • Protocols, ICF, case record forms
  • EU MDR Gap Analysis
  • UDI Consulting
  • CER / CEP Writing
  • Post Market Surveillance
  • Post clinical follow up activities

WHAT WE OFFER

The Bioviser Advantage

Plethora of services

Our services for pharmaceuticals/drugs include: (Publishing, Labelling, IDMP Consulting, Regulatory intelligence, and Regulatory Post-Marketing Compliance Support).

  • Regulatory medical writing and technical writing
  • eCTD services including clinical overviews; clinical summaries; clinical justification documents for EU, the US, and other emerging regulatory markets; and gap analysis for dossiers in clinical part
  • Our clinical study reports and clinical evaluation reports (for medical devices only) allow you to gain critical insights; we also support post-marketing clinical follow-up activities to support MDR requirements.
  • We do strategic labelling and design protocols, informed consent forms, and case record forms

Services for medical devices

Our services for Medical Devices include:

  • EU MDR gap analysis
  • UDI consulting
  • CER / CEP writing
  • Post-market surveillance
  • Medical device consulting

WHAT MAKES US COMPETITIVE

Partner with Bioviser

Well-trained, qualified analysts
(MD, MS, PhD)

Collaborate with the best in the industry

Technology-driven results

On-Cloud or On-Prem with Clinevo eCTD solutions

Regulatory grade quality

Our GDPR- and ISO-compliant adaptive technology solutions drive successful results

Customized solutions

Regulatory writing to fit your compliance needs

RESOURCES

Regulatory Affairs Resources

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problem? Let’s talk!

GET IN TOUCH

Humans of healthcare technology

Bioviser Inc.
6 Liberty Square # 2069
Boston, MA 02109

Phone - (617) 744-4748
Fax - (617) 812-5098
Email - [email protected]

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BIOVISER®. ALL RIGHTS RESERVED.

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Privacy Policy

This website (and any mobile site or applications that link to this privacy policy) (collectively, the “Sites”) is owned and operated by BIOVISER (“BIOVISER,” “we,” “our,” and “us”). Data privacy is important to BIOVISER and upholding your trust is our priority. This privacy policy explains how we collect and use personal data obtained through the Sites and other means such as email, in person, or from other third-party sources.

Contacting us

If you have any questions about our privacy policy or your information, or to exercise any of your rights as described in this privacy policy or under data protection laws, you can contact us:

By post: Bioviser Inc., 6 Liberty Square #2069, Boston, MA 02109

By email: [email protected]

Data protection principles

When processing your personal data, BIOVISER adheres to the following principles:

  1. Lawfulness, fairness, and transparency – data must be processed lawfully, fairly, and in a transparent manner
  2. Purpose limitation– data must be collected for specified, explicit, and legitimate purposes and not further processed in a manner incompatible with those purposes
  3. Data minimization– data must be adequate, relevant, and limited to what is necessary in relation to the purposes for which they are processed
  4. Accuracy– data must be accurate and, where necessary, kept up to date
  5. Storage limitation– data must be kept in a form that permits identification of data subjects for no longer than is necessary for the purposes for which the personal data are processed
  6. Integrity and confidentiality– data must be processed in a manner that ensures appropriate security of personal data—including protection against unauthorized or unlawful processing and against accidental loss, destruction, or damage—by using appropriate technical or organizational measures

Personal data we collect

To aid business operations and marketing, BIOVISER collects and processes information pertaining to a research panel, client, and other contact details. This information may include the following:

  • your name;
  • home address;
  • contact details (such as telephone number and email address);
  • date of birth;
  • gender;
  • marital status;
  • copies of passport, driving license, and similar documents; and
  • educational history, training, and professional experience.

Information you give us

You may provide us with information over the phone, email, or otherwise, when you:

  • request information or materials regarding our services or ask us to contact you;
  • complete any of our online forms—for example, when you complete the “Get in Touch” online forms; and
  • make any comment or contribution on our Sites.

Applicants for employment

We may also collect personal information from you when you apply for a job with us through our careers page or respond to a specific listed employment position with us.

This information may include your contact information, curriculum vitae, previous work experience, education, transcript, driver’s license information, social security number or national identification number, and information relating to references.

Information we collect online

When you interact with us online, we employ cookies and other technological tools to gather information about your device and your use of our Sites, such as IP address, referring website, pages visited on your device, and the time you visited our Sites on your device. We will use the assembled information:

  • to manage our Sites and for internal operations, including troubleshooting, data analysis, testing, research, and statistical and survey purposes;
  • to improve our Sites to ensure that content is presented in the most effective manner for you and for your computer; and
  • as part of our efforts to keep our Sites protected.

Information we collect from third parties

We directly collect most of this information from you. In addition, we receive information about you when you use any of the other websites we operate or avail of the other services we provide.

We also work closely with third parties (including, for example, business partners; subcontractors in technical, payment, and delivery services; analytics providers; search information providers; and credit reference agencies) and may receive information about you from them.

We also collect information about you:

  • from publicly accessible sources, e.g., Companies House;
  • from third-party sources of information, e.g., client due diligence providers;
  • which you have made public on websites associated with you or your company or on social media platforms such as LinkedIn; and
  • from a third party, e.g., a person who has introduced you to us or other professionals (such as accountants) you may engage.

Sensitive personal data

We do not generally seek to collect sensitive personal data through our Sites. Sensitive personal data is information relating to racial or ethnic origin, political opinions, religious or philosophical beliefs, trade-union membership, health or sex life, sexual orientation, and genetic data or biometric data. If we do collect sensitive personal data, we will request your explicit consent to our proposed use of that data at the time of collection.

Children

The Sites are not intended for, or directed at, children under the age of 16 years and we do not knowingly collect data relating to children under this age.

What we do with your personal data

The purpose for which we use and process your information and the legal basis on which we carry out each type of processing is explained below.

Purposes for which we will process the information

Legal basis for the processing

To enter into and perform contracts with you

It is necessary for us to process your personal data in this way in order to enter into a contract with you and to fulfill our contractual obligations to you.

To provide you with information and services that you request from us

It is in our legitimate interest to respond to your queries and provide any information requested in order to generate and develop business. To ensure we offer a good and responsive service, we consider this use to be proportionate and will not be prejudicial or detrimental to you.

To enforce the terms and conditions and any contracts entered into with you

It is in our legitimate interest to enforce our terms and conditions of service. We consider this use to be proportionate and necessary for our legitimate interests.

To populate our database intended for marketing purposes

It is in our legitimate interest to market our services. We endeavor to ensure that the contacts in our database are relevant and up-to-date. We consider this use to be proportionate and will not be prejudicial or detrimental to you.

You can always opt out of receiving direct marketing-related email communications or text messages by following the unsubscribe link.

To send you publications, event information, and marketing communications

It is in our legitimate interest to market our services. We consider this use to be proportionate and will not be prejudicial or detrimental to you.

For direct marketing sent by email to new contacts (i.e., individuals whom we have not previously engaged with), we will need your consent to send you unsolicited direct marketing.

To send you information regarding changes to our policies, other terms and conditions, and other administrative information

It is in our legitimate interest to ensure that any changes to our policies and other terms are communicated to you. We consider this use to be necessary for our legitimate interests and will not be prejudicial or detrimental to you.

·         To administer our Sites, including troubleshooting, data analysis, testing, research, and statistical and survey purposes

·         To improve our Sites to ensure that consent is presented in the most effective manner for you and your computer, mobile device, or other item of hardware through which you access the Sites

·         To keep our Sites protected

For all these categories, it is in our legitimate interest to continually monitor and improve our services and your experience of the Sites and to ensure network security. We consider this use to be necessary for our legitimate interests and will not be prejudicial or detrimental to you.

To measure or understand the effectiveness of any marketing we provide to you and others and to deliver relevant marketing to you

It is in our legitimate interest to continually improve our offering and develop our business. We consider this use to be necessary in order to effectively generate business and will not be prejudicial or detrimental to you.

For normal business purposes such as payment processing and financial account management, product development, contract management, website administration, fulfillment, analytics, fraud prevention, corporate governance, reporting, and legal compliance

It is necessary for us to process your personal data in this way in order to enter into a contract with you and to fulfill our contractual obligations to you.

Where we rely on legitimate interests as a lawful basis, we will carry out a balancing test to ensure that your interests, rights, and freedoms do not override our legitimate interests.

If you do not wish to provide us with your personal data and processing such information is necessary for the performance of a contract with you, we may not be able to perform our obligations under the contract between us.

BIOVISER will only use your personal data for the purposes for which we collected it, unless we reasonably consider that we need to use it for another reason and that reason is compatible with the original purpose. If we need to use your personal data for an unrelated purpose, we will notify you in a timely manner and will explain the legal basis that allows us to do so.

Email marketing

For email marketing to an individual subscriber (that is, a noncorporate email address) with whom we have not previously engaged as a client, we will need your consent to send you unsolicited email marketing.

Where you provide consent, you can withdraw your consent at any time, but without affecting the lawfulness of processing based on consent before its withdrawal.

You have the right to opt out of receiving email marketing communications from us at any time by:

  • contacting us using the contact details provided above; or
  • using the “unsubscribe” link in emails.

Disclosure of your personal data to third parties

BIOVISER will share such information with its consultants, contractors, affiliates, and advisers as necessary to carry out the purposes for which the information was supplied or collected.

Personal data will also be shared with our third-party service providers who assist with the running of our Sites and services, including marketing, database service providers, IT services such as backup and disaster recovery service providers, and others. Our third-party service providers are subject to security and confidentiality obligations and are only permitted to process your personal data for specified purposes and in accordance with our instructions.

In addition, BIOVISER will disclose information about you:

  • in the event that we sell or buy any business or assets, in which case we may disclose your personal information to the prospective seller or buyer of such business or assets;
  • if all or substantially all of BIOVISER’s assets are acquired by a third party, in which case personal information held by it about its customers will be one of the transferred assets;
  • if we are under a duty to disclose or share your personal information in order to comply with any legal obligation;
  • if necessary to protect the vital interests of a person; and
  • to establish, exercise, or defend the rights of BIOVISER, our staff, clients, or others.

Please note that we may also disclose information about you that is not personally identifiable; for example, we may publish reports that contain aggregated and statistical data about our customers’ products. These reports do not contain any information that would enable the recipient to contact, locate, or identify you.

International transfers

BIOVISER operates with staff, vendors, and offices in many countries around the globe. The personal data and professional information you provide to BIOVISER may be processed, transferred, and shared with individuals in different countries for the purpose of routine business uses.

Security of your personal data

BIOVISER uses appropriate technical and organizational safeguards to protect personal data, both online and offline, from unauthorized use, loss, or destruction. We use industry standard physical and procedural security measures to protect information from the point of collection to the point of destruction. This includes encryption, firewalls, access controls, policies, and other procedures to protect information from unauthorized access.

Only authorized personnel and third-party service providers are permitted access to personal data, and that access is by need. Where data processing is carried out on our behalf by a third party, we take steps to ensure that appropriate security measures are in place to prevent the unauthorized disclosure of personal data.

Despite these precautions, however, BIOVISER cannot guarantee the security of information transmitted over the Internet or that unauthorized persons will not obtain access to personal data. In the event of a data breach, BIOVISER has introduced procedures to deal with any suspected breach and will notify you and any applicable regulator of a breach where required to do so.

How long we keep your personal data

Your personal data will not be kept for longer than is necessary for the purposes for which it was collected and processed.

The following are the criteria used for retaining your personal data:

  • General queries and correspondence– when you make an enquiry or contact us by email or telephone, we will retain your information for as long as necessary to respond to your queries. After this period, we will not hold your personal data for longer than one year if we have not had any active subsequent contact with you;
  • Direct marketing– where we hold your personal data in our database for direct marketing purposes, we will retain your data for no longer than two years if we have not had any active subsequent contact with you.
  • Legal and regulatory requirements– we may need to retain personal data for up to 7 years, where necessary, to comply with our legal obligations, resolve disputes, or enforce our terms and conditions.

Your rights

Access to and updating your personal data

You have the right to access information that we hold about you (“data subject access request”). You also have the right to receive your personal information in a structured and commonly used format so that it can be transferred to another data controller (“data portability”).

We want to ensure that your personal information is accurate and up-to-date. You may ask us to correct or remove information you think is inaccurate. Please keep us informed if your personal data changes during your relationship with us.

Right to object

Direct marketing

You have the right to object at any time to our processing of your personal information for direct marketing purposes.

Where we process your information based on our legitimate interests

You have the right to object, on grounds relating to your particular situation, at any time to processing of your personal information that is based on our legitimate interests. Where you object on this ground, we shall no longer process your personal information unless we can demonstrate compelling legitimate grounds for the processing that will override your interests, rights, and freedoms or for the establishment, exercise, or defense of legal claims.

Your other rights

Under data protection laws, you have the right to request that we rectify your personal information that is inaccurate or incomplete.

In certain circumstances, you have the right to:

  • request the erasure of your personal information (“right to be forgotten”); and
  • restrict the processing of your personal information to processing in certain circumstances.

Please note that the above rights are not absolute and we may be entitled to refuse requests, wholly or partly, where exceptions under the applicable law apply.

Exercising your rights

You can exercise any of your rights as described in this privacy policy and under data protection laws by contacting us as provided in the “Contacting us” section above.

Save as described in this privacy policy or provided under data protection laws, there is no charge for the exercise of your legal rights. However, if your requests are manifestly unfounded or excessive, in particular because of their repetitive character, we may either (a) charge a reasonable fee taking into account the administrative costs of providing the information or taking the action requested or (b) refuse to act on the request.

Where we have reasonable doubts concerning the identity of the person making the request, we may ask for additional information that is necessary to confirm your identity.

Links

From time to time, the Sites may contain links to and from the websites of our partner networks, advertisers, and affiliates.

If you follow a link to any of these websites, please note that these websites have their own privacy policies and BIOVISER does not accept any responsibility or liability for these policies. Please check these policies before you submit any personal information to these websites.

Complaints

If you have any questions or complaints regarding our privacy policy or practices, please contact us as provided in the “Contacting us” section above.

Changes to our privacy policy

We will only use your personal information in the manner described in this privacy policy. However, we reserve the right to change the terms of this policy at any time by posting revisions to our Sites.

If we make any material changes to this policy, we will place a prominent notice on our Sites.

At any point, if we decide to use personal information in a manner different from that stated at the time it was collected, you will be given a choice to allow or disallow any additional uses or disclosures of your personal information beyond that which was stated in this policy at the time your information was collected.

This privacy policy was last updated on 25 January 2022.

Terms of Service

Terms

BIOVISER operates this Web site to provide online access to information about BIOVISER and the products, services, and opportunities we provide. Your access and use of this Web site are subject to the following terms and conditions and constitutes acceptance of these terms (“Terms of Use”). 

BIOVISER reserves the right to modify these Terms of Use at any time without giving you prior notice. Your use of the Web site following any such modification constitutes your agreement to follow and be bound by the Terms of Use as modified.

License and Access

You may use the Web site, and the information, writings, images and/or other works that you see, hear or otherwise experience on the Web site (singly or collectively, the “Content”) solely for your non-commercial, personal purposes and/or to learn about BIOVISER products and services. No right, title or interest in any Content is transferred to you, whether as a result of downloading such Content or otherwise. BIOVISER reserves complete title and full intellectual property rights in all Content. Except as expressly authorized by these Terms of Use, you may not use, alter, copy, distribute, transmit, or derive another work from any Content obtained from the Web site, except as expressly permitted by these Terms of Use.

Copyright

BIOVISER, its suppliers or the original creator of the Content own all copyrights to Content on the Web site and all other intellectual property rights related to the Web site. To the extent that BIOVISER has the right to do so without compensation to third parties and except for Content specifically provided under other terms, BIOVISER grants you permission to copy Content on the Web site solely for your non-commercial use in support of BIOVISER products. You agree that any copies of the Content shall retain all copyright and other proprietary notices in the same form and manner as the original. You may not, without BIOVISER’s permission, “mirror” any Content contained on the Web site or any other server. Except as specified above, nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any trademark, patent, copyright, or any other intellectual property right of BIOVISER or any third party.

Trademarks

The trademarks, logos, service marks, brand identities, title, characters, trade names, graphics, designs, and other properties (collectively the “Trademarks”) displayed on the BIOVISER Web site are protected intellectual properties that are registered and unregistered trademarks of BIOVISER, its affiliates and others. Nothing contained on the BIOVISER Web site should be construed as granting, by implication, or otherwise, any license or right to use any Trademark displayed on this Web site without the written permission of BIOVISER or such third party that may own the Trademark displayed on BIOVISER’s Web site. Your misuse of the Trademarks displayed on BIOVISER’s Web site, or any other content on BIOVISER’s Web site, except as provided herein, is strictly prohibited.

Privacy

Information Provided to BIOVISER

BIOVISER does not want you to, and you should not, send any confidential or proprietary information to BIOVISER via the Web site. Any submission by you to BIOVISER, including but not limited to questions, comments, suggestions or the like shall be deemed to be non-confidential and shall become the property of BIOVISER. Furthermore, by your submission you grant BIOVISER an unrestricted, irrevocable license to use, reproduce, display, perform, modify, transmit, and distribute such information. BIOVISER shall be free to use any ideas, concepts, know-how or techniques contained in such information for any purpose whatsoever, including but not limited to developing, manufacturing, and marketing products incorporating such information

Electronic Communications

When you visit www.BIOVISER.com or send e-mail to us, you are communicating with us electronically. Accordingly, you explicitly consent to receive communications from us electronically. We will communicate with you by e-mail or by posting notices on this Web site. You agree that all agreements, notices, disclosures, and other communications that we provide to you electronically satisfy any legal requirement that such communications be in writing.

Disclaimer of Warranties

BIOVISER MAKES NO EXPRESS OR IMPLIED WARRANTIES, REPRESENTATIONS OR ENDORSEMENTS WHATSOEVER WITH RESPECT TO THE WEB SITE OR THE CONTENT. BIOVISER EXPRESSLY DISCLAIMS ALL WARRANTIES OF ANY KIND, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT, WITH REGARD TO THE WEB SITE, THE CONTENT, AND ANY PRODUCT OR SERVICE FURNISHED OR TO BE FURNISHED VIA THE WEB SITE. BIOVISER DOES NOT WARRANT THAT THE FUNCTIONS PERFORMED BY THE WEB SITE WILL BE UNINTERRUPTED, TIMELY, SECURE OR ERROR-FREE, OR THAT DEFECTS IN THE WEB SITE WILL BE CORRECTED. BIOVISER DOES NOT WARRANT THE ACCURACY OR COMPLETENESS OF THE CONTENT, OR THAT ANY ERRORS IN THE CONTENT WILL BE CORRECTED. THE WEB SITE AND THE CONTENT ARE PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS.

Limitation of Liability

IN NO EVENT WILL BIOVISER BE LIABLE FOR ANY DAMAGES WHATSOEVER, INCLUDING, BUT NOT LIMITED TO ANY DIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR OTHER INDIRECT DAMAGES ARISING OUT OF (I) THE USE OF OR INABILITY TO USE THE WEB SITE OR THE CONTENT, (II) ANY TRANSACTION CONDUCTED THROUGH OR FACILITATED BY THE WEB SITE; (III) ANY CLAIM ATTRIBUTABLE TO ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE WEB SITE, THE SERVICE AND/OR THE CONTENT, (IV) UNAUTHORIZED ACCESS TO OR ALTERATION OF YOUR TRANSMISSIONS OR DATA, OR (V) ANY OTHER MATTER RELATING TO THE WEB SITE, OR THE CONTENT, EVEN IF BIOVISER HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IF YOU ARE DISSATISFIED WITH THE WEB SITE, THE CONTENT, OR WITH THE TERMS OF USE, YOUR SOLE AND EXCLUSIVE REMEDY IS TO DISCONTINUE USING THE WEB SITE.

BECAUSE SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, SOME OF THE ABOVE LIMITATIONS MAY NOT APPLY TO YOU. IN SUCH STATES, BIOVISER’S LIABILITY IS LIMITED AND WARRANTIES ARE EXCLUDED TO THE GREATEST EXTENT PERMITTED BY LAW, BUT SHALL, IN NO EVENT, EXCEED $100.00.

Digital Millennium Copyright Act

BIOVISER is committed to complying with U.S. copyright law and to responding to claims of copyright infringement. BIOVISER will promptly process and investigate notices of alleged infringement and will take appropriate actions under the Digital Millennium Copyright Act, Title 17, United States Code, Section 512(c) (“DMCA”).

Pursuant to Title 17, United States Code, Section 512(c)(2), notifications of claimed copyright infringement should be sent to BIOVISER’s Designated Agent. 

 

 

Cookies

When you visit our Sites, we collect certain information by automated means, using technologies such as cookies, pixel tags, browser analysis tools, server logs and web beacons.

For example, when you visit our Sites, we place cookies on your computer. Cookies are small text files that websites send to your computer or other Internet‐connected device to uniquely identify your browser or to store information or settings in your browser. Cookies allow us to recognize you when you return, they are used in order to make websites work, or work more efficiently, as well as to provide information to the owners of the website.

Our Sites use the following types of cookies:

  • Strictly necessary cookies – these enable you to move from page to page within our Sites and to use any features on the Sites. These cookies are deleted when you close your browser.
  • Performance cookies – these allow us to collect information, including the number of visitors to our Sites; where they have come to our Sites from; the pages they visit; and the length of time they have spent on our Sites.

The table below explains more fully what cookies are used on our Sites.

Types of Cookie

  • Essential website cookies: These cookies are strictly necessary to provide you with services available through our Website and enables you to move from page to page within our website and to use its features. These cookies are deleted when you close your browser.
  • Performance and functionality cookies: These cookies are provided by Google Analytics and are used to enhance the performance and functionality of our Website but are non‐essential to their use. However, without these cookies, certain functionality may become unavailable.
  • Analytics and customization cookies: These cookies collect information that is used either in aggregate form to help us understand how our Website is being used or to help us customize our Website for you.
  • Social networking cookies: These cookies are used to enable you to share pages and content that you find interesting on our Website through third party social networking and other websites; specifically the Facebook button, Twitter button and Linkedin button. These cookies may also be used for advertising purposes too.

Blocking Cookies

You have the right to decide whether to accept or reject cookies. You can exercise your cookie preferences by clicking on the appropriate opt‐out links provided.

You can also set or amend your web browsers controls to accept or disable cookies. Most Web browsers automatically accept cookies, but you can usually modify your browser settings to disable cookies if you prefer. If you decide to disable cookies, you may not be able to access some areas of our Sites.

Social Media Plugins

This Site uses social medial plugins (e.g. the Facebook “Share” button, Twitter “Share” button and Linkedin “Share” button) to enable you to easily share information with others. When you visit our Sites, the operator of the social plugin can place a cookie on your computer, enabling that operator to recognize individuals who have previously visited our Site. If you are logged into the social media website (e.g. Facebook, Twitter) while browsing on our Sites, the social plugins allow that social media websites to share information about your activities on our Sites with other users of their social media website.

For example, Facebook Social Plugins allows Facebook to show your Likes and comments on our pages to your Facebook friends. Facebook Social Plugins also allows you to see your friends’ Facebook activity on our Sites. BIOVISER   does not control any of the content from the social media plugins. For more information about social plugins from other social media websites you should refer to those sites’ privacy and data sharing statements.

LinkedIn 

We have enabled ‘Maximum’ data-sharing with LinkedIn to help improve the relevance of adverts shown to users based on customer data. Customer’s personal information (name, location, email address, phone number, and browsing behaviour on our website) is used to create lookalike audiences on LinkedIn’s network. This means that this website uses LinkedIn’s Conversions API and pixel. Using the customer’s web browser, data is shared directly with LinkedIn’s servers. This data can’t be blocked by browser-based ad blockers.

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Haruyoshi Ogata

PRESIDENT - APAC OPERATIONS

Haruyoshi has had extensive experience working with key persons across pharmaceutical and medical device companies, publishers, editorial boards, international societies, and KOLs. With over 20 years of experience in business development and marketing across multiple industries, he has shared his expertise with many clients.

Haruyoshi has knowledge of publishing industries, business communication, and culture of Japan as well as the APAC region. As the manager of business development for a global publisher, he launched the science communication department. During this period, he conducted educational seminars for publication ethics and publication planning. He also has in-depth experiences as a branch manager in the publication industry of Australia for three years.

Haruyoshi has served as Director, Business Development, at one of the global medical communication agencies and has been involved in over 100 scientific publication projects and the launch of international journals. In addition, he has expertise in publication strategies, pub SOP, and policy developments.

Haruyoshi has been a part of the medical communications team (including medical writing) that aided pharmaceutical and medical device companies, which published work by Japanese clinical researches and studies in global journals. He has helped to publish several articles and supplements in journals.

K. G. Mathew Tharakan

VICE PRESIDENT - GOVERNMENT SOLUTIONS

Mathew has 30 years of experience in transportation operations and engineering management along with professional expertise in rail vehicle engineering at Southeastern Pennsylvania Transportation Authority (SEPTA). In 2016, he joined SEPTA’s business division as a Disadvantaged Business Enterprise Manager, overseeing the participation of minority and women-owned businesses in procurement and major construction contracts.

As part of a cost-saving strategy, Mathew was asked to set up a new material warranty department for SEPTA. He was additionally tasked with the rewriting of SOPs and policies for their supply chain division. For over three decades, he has occupied various Asian American leadership positions, particularly Indian American community leadership roles in Philadelphia and Bucks and Montgomery counties.

Mathew graduated from the 2013 Pennsylvania Political Leaders Fellowship Program (CPL), and has extensively travelled and researched the Pennsylvania political landscape. Nationally, he was involved in grassroot organizing, fundraising, faith-based initiatives, and President Obama’s Asian American affairs and White House community partnership program. Moreover, he has served as the president of Conference of Minority Transportation Officials, a national organization with 40 chapters across the United States that is committed to the diversity and progress of minorities in the transportation industry. He further co-chaired Mayor Kenney’s transportation and infrastructure transition committee and was appointed as a member of the mayor’s advisory commission on Asian American affairs in July 2016.

In 2018, Mathew was asked to serve on the Bucks county transportation commission to assist with the Middletown township’s traffic development program. He has an MBA in finance and a master’s in computer science from Philadelphia University. In addition, he has a bachelor’s degree in history and political science from Loyola College University, Madras, and a diploma in electrical technology from Kerala University.

At Bioviser, Mathew supports business development activities for government solutions with prime contractors for data analytics. He is presently working on his doctoral program in business administration with an emphasis in data analytics.

Roque Pereira

CHIEF FINANCIAL OFFICER (CFO)

Roque is a natural-born leader and has been successfully running a leading emergency and medical care practice for 27 years in Virginia, USA. Additionally, having earned his degree from Bombay Veterinary College in 1977, he has been actively practicing veterinary medicine for 44 years. Among his many achievements, Roque is a member of the DC Academy of Veterinary Medicine.

As a business owner, Roque has been safeguarding the vital assets of his company by reducing risks and accurately maintaining/closing books; operating an efficient and effective financial structure through planning, analysis, and remedial measures; strategizing in various ways to influence the future direction of his company; and stimulating and driving business growth initiatives such as improved company cost reduction, procurement, pricing execution, and other innovations adding value to the company. Additionally, he has been making decisions related to team recruitment and people management, patient records, and compliance to IRS and OSHA standards. Further, he has been regularly attending national and international conferences.

As the CFO at Bioviser, Roque is primarily responsible for providing financial leadership and aligning business and finance strategies to grow the business. When he is not working, Roque loves to garden, bike, visit national parks, and travel to other countries.

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Haruyoshi Ogata

PRESIDENT - APAC OPERATIONS

Haruyoshi has had extensive experience working with key persons across pharmaceutical and medical device companies, publishers, editorial boards, international societies, and KOLs. With over 20 years of experience in business development and marketing across multiple industries, he has shared his expertise with many clients.

Haruyoshi has knowledge of publishing industries, business communication, and culture of Japan as well as the APAC region. As the manager of business development for a global publisher, he launched the science communication department. During this period, he conducted educational seminars for publication ethics and publication planning. He also has in-depth experiences as a branch manager in the publication industry of Australia for three years.

Haruyoshi has served as Director, Business Development, at one of the global medical communication agencies and has been involved in over 100 scientific publication projects and the launch of international journals. In addition, he has expertise in publication strategies, pub SOP, and policy developments.

Haruyoshi has been a part of the medical communications team (including medical writing) that aided pharmaceutical and medical device companies, which published work by Japanese clinical researches and studies in global journals. He has helped to publish several articles and supplements in journals.

Keerti Bhagwat

SENIOR VICE PRESIDENT - FUNCTIONAL SERVICES

Keerti has over 24 years of experience in managing operations and delivery systems in the healthcare industry. Her strengths lie in building strategic relationships, strengthening client trust, and driving business diversification and organic growth. She has proficiently managed mid- to large-scale client accounts of top global pharmaceutical, biologics, and medical device organizations headquartered in the US, EU, and Japan.

Over the past two decades, Keerti has managed operations for end-to-end pharmacovigilance/drug safety case processing for global and local pharma companies for their global and local case submissions. She has successfully set up and strengthened delivery teams in India, Tokyo and Osaka in Japan, and Dalian and Shanghai in China.

With a strong inclination to weave technology into her processes, Keerti has built digital solutions for data entry (case processing) for low complex cases using various off-the-shelf RPA and AI applications. She has expertise in building processes, metrics and SLAs, and the overall delivery model suitable for case processing.

Keerti has led several strategic initiatives for initiation of new delivery site locations for Life Sciences and has successfully initiated new international sites in the US, Poland, Hungary, Germany, Philippines, Singapore, Japan, and China as well as Kolkata and Pune locations in India. She also has experience in delivering end-to-end projects (contracting to project confirmation to steady state) in collaboration with global teams.

Santhosh Sirupa

DIRECTOR - OPERATIONS

A pharmacist by qualification, Santhosh has a master’s degree in pharmaceutics from Cromwell College, UK. Also, he has an M.S. in general chemistry from MTSU, USA. At MTSU, he was awarded graduate assistantship for two years for achieving high GPAs. He has over 14 years of experience in managing operations and delivery systems in the clinical research and drug safety industry. He also has extensive experience in pharmacovigilance, data analysis, and clinical research. He has proven himself as a successful delivery manager with competent team management skills.

Over the last five years, Santhosh earned a reputation for providing scalable business operational solutions that meet demanding time constraints and exceed expectations. He has worked with numerous prestigious organizations such as Accenture, Novartis, Syneos Health (formerly known as InVentiv), and Cognizant Technology Solutions Pvt. Ltd. His expertise lies in streamlining quality operations and controlling and coordinating for the improvement of deliverables.

As an SME, Santhosh has sound knowledge of pharmacovigilance and regulatory activities. He is an experienced corporate global trainer who has trained over 150 associates in pharmacovigilance across the globe.

Santhosh has headed an independent quality control team at the portfolio level, has been responsible for multiple accounts, and has acted as a BQA (preparing for audits, facing client audits, conducting internal audits, and highlighting risks). He has been actively involved in determining, negotiating, and agreeing on in-house quality procedures, standards, and specifications as well as assessing customer requirements and ensuring that they are met. He has participated in important activities such as setting customer service standards, investigating and setting standards for quality, and ensuring that processes comply with standards at both national and international levels. He has closely worked with cross-functional teams to establish standards, systems and procedures, writing management and technical reports, and customer’s charters; to determine training needs; and to implement proposed CAPAs. He has acted as a catalyst for change and improvement in performance and quality.

Ivan Dsouza

CHIEF EXECUTIVE OFFICER (CEO)

Over the years, Ivan has built a solid multifunctional foundation in the healthcare industry, working at various leadership positions. He has lent his expertise to strategy, business and product offering expansion, team building, sales, delivery, client servicing, training and development, and recruitment.

With over 15 years of experience in business, Ivan has been a significant contributor to the growth of numerous businesses. He has consulted clients for clinical research solutions in India and has continued to grow such services in major markets like the US, EU, and Japan along with growing business regions such as China, Taiwan, South Korea, and India.

Ivan has built teams in these regions and extensively travelled to manage numerous customer relationships with budgets of millions of dollars. His strengths lie in customizing solutions; one of his greatest achievements was to design a customized business solution in pharmacovigilance with a novel partnering idea that won his company a deal of over $10M.

Beyond Bioviser, Ivan maintains an active presence in the industry ecosystem by being a member on numerous forums. He loves supporting and encouraging entrepreneurship. He also serves as a member of a few clinical research ventures’ advisory boards and helps accelerate their journey to commercial success. Despite several work commitments, Ivan loves to carve out time to share a wealth of knowledge with his industry peers and is a guest lecturer at various leading clinical research institutes. Additionally, he is a speaker at industry conferences on clinical research.