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
Clinical Investigation Approvals: An Overview of Forms MD-22 and MD-23
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..
Regulatory Challenges of SaMD: Navigating Global Standards and Compliance
Navigating Software as a Medical Device regulation involves addressing varying global standards, including risk-based classifications...
The Future of SaMD: Emerging Trends and Innovations
The future of Software as a Medical Device will see breakthroughs in Artificial Intelligence-based diagnostics, personalised treatments, and remote monitoring...