Your Trusted Partner in Patient Safety with Pharmacovigilance Services
Bioviser offers 360-degree pharmacovigilance services through expert consulting and best-in-class technology. By combining smart processes and artificial intelligence, we design solutions that allow healthcare companies to make better, informed, and faster decisions.
Our certified team identifies your unique requirements and customizes solutions just for you. We help our clients to optimize patient safety solutions. Working synchronically, our regulatory consulting services allow you to maintain control of your pathway and stay ahead of any compliance risks. With practical interpretation, we help you to understand how global regulatory guidelines apply to you.
HOW WE HELP
Supporting and Scaling Pharmacovigilance Services Journey
Our team of professional experts support you through the entire pharmacovigilance journey, right from proof-of-concept to post marketing surveillance services. We offer a high level of expertise and assist in meeting the highest standards of applicable national and global regulations.
With our vast pool of trained accessible resources, Bioviser is capable of scaling when your business expands, to handle large case volumes. We understand the need to be flexible in the ever-dynamic medical and healthcare industry.
WHAT WE OFFER
The Bioviser Advantage
Case Processing support
At Bioviser, we offer case processing support which includes case intake, triage, data entry, quality review, medical review, and regulatory submission. We cater to literature case management (local and global) activities as well as aggregate reporting and signal detection activities too.
Risk Management consulting
We do risk management consulting for identifying, validating, and segregating safety data into important identified, potential risk and missing information. Risk evaluation and mitigation strategies (US-REMS)-preparation of communication plans, medication guides and other relevant safety data for REMS for effective implementation and timely submissions are also our core strengths.
Audit, Inspection and Training
We offer audit and inspection readiness support and comprehensive pharmacovigilance training to companies. Our best-in-class team is competent at aggregate report writing (PSURs, PBRERs, DSURs, and PADERs) and providing EU QPPV services that are tailored to each client.
Proactive and Collaborative support
We ensure that critical and time-sensitive requests are given priority and treated in an expedited manner. Bioviser adopts a proactive and collaborative approach with every client to ensure maximised quality and drive continuous improvement.
Minimise risk of error
Our independent QA reviewers minimize the risk of errors and identify literature cases across PubMed, Embase, Cochrane, and Econlit. We strive to adopt process agility by liaising with a team that is knowledgeable in USFDA, EMA, MHRA, and other global regulatory requirements.
WHAT MAKES US COMPETITIVE
Partner with Bioviser
Well-trained, qualified analysts
(MD, MS, PhD)
Collaborate with the best in the industry
Our team is experienced in working with various platforms like ARGUS, Arisg, and Clinevo.
Regulatory grade quality
Our GDPR- and ISO-compliant adaptive technology solutions drive successful results