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
The Cosmeceuticals Grey Zone: When a Cosmetic Claim Risks Becoming a Drug Claim
“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..
Ingredient Safety Dossiers: Building a Defensible Package for Novel Actives
Companies developing Cosmetics with new or unusual active ingredients face a higher regulatory bar in India than those using well-established formulations. Understanding what “new” means under the..
Cosmetic Claims Substantiation: What Counts as Evidence Under Indian Rules
Walk down any Cosmetics aisle and you will see claims like “clinically proven,” “dermatologist tested,” or “reduces fine lines in two weeks.” These claims sell products — but under the C..
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