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:

Clinwell team helps meet all the legal requirements of an IND application and fosters the communication between sponsor and FDA’s new drug review division by reviewing internal IND principles, policies and procedures and assisting in preparation of guidance document.