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 and up-to-date regulatory intelligence (NMPA, FDA, EMA, TGA, PMDA, MFDS, etc.）
- Product development consulting services from pre-IND activities through post-approval changes
- 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 (NMPA, FDA, EMA, TGA, PMDA, MFDS, etc.）
- Establishment registration including Site Master File/Plant Master File for facilities and equipment
- Full support for Health Authority inspections to enable successful product licensure/registration
- Regulatory approval pathways
Experienced in projects
Intellective Bio has long-term cooperation with many first-tier pharmaceutical companies and has rich experience in large-scale projects, covering types including dual antibodies, Fc fusion proteins, ADCs, nanoantibodies, fusion proteins, ADCs (nanoantibodies), monoclonal antibodies, CAR-raNK cell products, cellular therapeutic products and vaccines. One project has been approved for marketing, 12 late-stage clinical projects have been signed, and 2 projects have passed on-site verification.
