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.
A quick guide on the Class A & B Medical Device manufacturing license — covering State FDA rules, Form MD-3/MD-5, fees, and timelines for manufacturers. Every manufacturer entering India’s..
A brief guide on Cosmetic import NOC India — covering when small quantity Cosmetic import for R&D testing bypasses full registration under Cosmetic rules 2020. Not every Cosmetic shipment into I..
“Cosmeceutical” is a popular marketing word. It suggests something more powerful than an ordinary Cosmetic — a product that treats skin condition, not just improves appearance. The problem is th..