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
Role & Responsibilities of Authorized Agent for Drugs in India
The role of authorized agent responsibilities is critical for foreign Pharmaceutical companies seeking to register, Import, and market Drugs in India while ensuring full regulatory compliance wi..
How to Get a CDSCO Import License in India: A Step-by-Step Guide for Foreign Medical Device Companies
In India given its large population and ample growth opportunities, remains one of the most attractive markets for global Medical Devices company. But entering Indian market is not so easy as it not o..
Pharmacovigilance Regulations For Imported Drugs In India
Pharmacovigilance ensures that Drugs are continuously monitored for safety, quality, and efficacy through structured reporting systems and regulatory oversight mechanisms post-approval. In India, the ..
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