Regulatory Affairs

Interaction with regulatory agencies:

  • Direct interaction and efficient communication with regulatory saves crucial time for the project.

  • Knowledge of current regulations and understanding of regulatory environment ensures smooth and efficient drug development process.

DCGI approvals for clinical trials:

  • Review and preparation of efficacy and safety data from preclinical/animal / clinical studies for presentation to DCGI.

  • Faster approvals of clinical trial protocol from DCGI.

IND / Drug registration: