CliniRx has a dedicated, in-house regulatory department overseeing and achieving timely regulatory submissions on behalf of our Sponsors. We will liaise with the regulatory agency of India to receive necessary approvals for the following:

• Clinical trial application
• Prepare clinical trial authorization dossier
• Produce submission documents to other regulatory authorities
• Facilitate regulatory review for fast track development drugs
• Manage drug import and export licensing
• Provide post submission support (i.e., annual reports and amendments)
• Prepare final report and submission
• Marketing application preparation