In order to strengthen the scientific review and approval of new drugs/devices, the ministry has appointed 12 New Drug Advisory Committee’s (NDAC), Subject Expert Committees (SEC) and 7 Medical Device Advisory Committee’s (MDAC) to advise the CDSCO in making their decisions on approval of new drugs and global clinical trials.
In order to strengthen the scientific review and approval of new drugs/devices, the ministry has appointed 12 New Drug Advisory Committee’s (NDAC), Subject Expert Committees (SEC) and 7 Medical Device Advisory Committee’s (MDAC) to advise the CDSCO in making their decisions on approval of new drugs and global clinical trials.The Committee members review the safety and efficacy data submitted with the application and subsequently the decision on the product is taken in the meeting, where industry representatives require to present the data pertaining to concerned projects.We have already attended numerous NDAC/SEC and MDAC meetings and this has enabled us to understand the approach of experts. We offer following invaluable services pertaining to NDAC/SEC/MDAC meeting.
The NDAC/MDAC meetings are held for following type of applications
New Drug Approval
New Device Approval
Import, registration and marketing authorization of New drug / Devices / Biological /Vaccines etc.
BE NOC for export of unapproved drugs
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