Regulatory Services:

Our teams are well equipped, trained and proficient in providing regulatory support for our clients in the following areas:

• Preparation, review and submission of Clinical Trial Application (CTA) and dossier.
• Protocol presentation (prior to start of study) & Clinical Study report (after completion of study) to Regulatory Authorities/Expert committee for obtaining approvals of the same.
• Preparation and submission of study status to ECs at site-level and also to the National Regulatory Authorities as per the guidelines.