NDAC meeting Support
The success of any new drug or FDC largely depends on the rationale and justification for using it. In line with the new regulations at CDSCO, all cases of new drugs, FDCs, New Devices, Global Clinical Trials etc are discussed by the NDAC expert committee of concerned therapeutic area in the presence of the sponsor before granting approval. CliniExperts have the capabilities to represent sponsor at the NDAC meeting. We can also evaluate sponsor’s proposal and can guide them to handle their cases at the at NDAC meeting.
Recent Posts
80 Categories, One Product: How to Get Cosmetic Product Categorisation Right in India
The Categorisation Problem Of all the challenges in India’s Cosmetic Import registration process, product categorisation is one of the most underestimated. Under the Cosmetics Rules, 2020, CDSCO..
Authorized Agent for Medical Device Import in India: When You Need One and How to Choose the Right Partner
For foreign Medical Device companies entering India, the authorized agent is not just a compliance checkpoint — it is a strategic regulatory role. The right appointment can support licensing procedu..
How to Obtain CDSCO Approval for Biosimilars in India: Complete 2026 Regulatory Pathway
Why India Demands a Dedicated Biosimilar Strategy India is one of the fastest-growing Biosimilar markets in the world, driven by a large patient population, expanding government healthcare coverage un..
Need Help?
Submit your EnquiryOffice Locations
- Delhi
- Bangalore
- USA
- Singapore