The human health division is a HPRA (Health Products Regulatory Authority) licensed company for the manufacture of medicines licenses. Chanelle Medical and our partners currently hold approximately 1,000 medicines licenses Marketing Authorisations all around the world. This has been achieved by our knowledgeable Regulatory Affairs Team which consists of highly qualified regulatory executives with 50 years combined experience.
Chanelle Medical Regulatory Affairs department offers our partners and clients with worldwide regulatory assistance with:
- – Compilation and submission activities of Marketing Authorisation applications through the most appropriate regulatory submission pathway
- – Expert Report writing, pharmacovigilance, variations, renewals etc.
- – Management of bio-equivalent studies, protocol approval and expert report preparation
- – Support to overcome critical regulatory and quality hurdles
Chanelle Medical Regulatory Affairs department strives to be constantly up-to-date with all the latest regulatory changes by continuous monitoring of international legislation, guidelines and customer practices.