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.
Introduction Looking for Cosmetic Label Compliance India? Are you a cosmetic manufacturer or importer navigating the complex world of Indian regulations? Ensuring your product labels comply with the l..
Summary Short Description Strict regulatory protocols govern clinical investigations for medical devices. Central to this process are forms MD-22 and MD-23. Form MD-22 is an application to Central Lic..
Navigating Software as a Medical Device regulation involves addressing varying global standards, including risk-based classifications...
New Delhi
Unit No. 324 & 325, City Centre Mall, Plot No. 5, Sector 12, Dwarka, India - 110075
+917672005050
Bengaluru
RMZ Galleria, 1st floor, Ambedkar Colony, Yelahanka, Bengaluru, Karnataka, India – 560064
Sales: +91 7672005050
Reception: +91-11-45214546
9 am to 6 pm (Monday to Friday)