Our regulatory affairs department supports all aspects of the product development lifecycle. From early
discovery considerations to clinical and commercial filing, to post-approval strategies for site addition and
scale-up, a dedicated regulatory professional matching your needs will be assigned. Together, we help manage
your regulatory complexity.
Why Us?
- Global regulatory affairs expertise (US FDA, EMA, NMPA, Health Canada, etc.)
- Product development consulting services from pre-IND activities through post-approval changes
- Regulatory approval pathways
- Tech transfer and scale-up CMC regulatory strategies
- CMC dossier preparation (CTD modules 2.3 and 3, English and Chinese), including support for agency communications and responses, from IND to BLA and post-approval submissions
- Health Authority meetings (US FDA, EMA, NMPA, PMDA, Health Canada, etc.)
- Establishment registration including Site Master File/Plant Master File for facilities and equipment
- Full support for Health Authority GMP inspections to enable successful product licensure/registration
- Up-to-date regulatory intelligence
IND Tracker
Blue = Approved/cleared
Orange = To be submitted or under review
