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.
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
On-Cloud or On-Prem with Clinevo eCTD solutions
Regulatory grade quality
Our GDPR- and ISO-compliant adaptive technology solutions drive successful results
Regulatory writing to fit your compliance needs