End to End Regulatory Services
Maximizing chance of first time approval, India specific protocol recommendations and current up to date Regulatory body concerns, patient mix and optimization for both DCGI and USFDA.
Submission Packet & Documentation
Review, Creation and Submission of Clinical Trial Application to DCGI and Local Ethics Committees. Ongoing maintenance of all communication, updating and management.
Face to Face meetings
Attend all meetings with Regulatory Authority. Assemble required experts as needed and negotiate with the DCGI.