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
India as a Cosmetic Manufacturing Hub: CDSCO, BIS, and the Regulatory Enablers for Global Manufacturers
The Strategic Shift For most global Cosmetic brands, India’s regulatory journey has begun with import registration — the COS-2 pathway explored throughout this series. But for a growing ..
Post-Market Surveillance Under Medical Device Rules, 2017
Regulatory approval is often treated as the finish line. In reality, for Medical Device and IVD manufacturers in India, it marks the start of an equally demanding obligation: Post-Market Surveillance ..
How to Sequence Global and India Market Entry for Medical Devices Without Creating Regulatory Rework
One of the most avoidable and expensive mistakes in Medical Device commercialisation is Regulatory rework — the process of going back to redo documentation, testing, or submissions because the..
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