Regulatory Affairs

We understand that regulatory affair is very important part of clinical research, so we make your life easy by undertaking all your regulatory affairs needs for Study conduction.

Our expertise and experience in understanding Indian regulatory requirements which facilitates swift approvals in India. We can help you to get faster regulatory & Ethic committee clearance for your protocols and dossiers

Our services:

  • Regulatory Strategy - Strategic design for the global regulatory submissions including the key markets of the UK, EU, USA, and Canada, but not limited to.
  • Regulatory Submissions - Gap Analysis/ Due-diligence and dossier review.
  • eCTD review, submission and publication.
  • Customized support on specific modules as per need can also be provided.
  • Query Management - Handling query responses from the regulatory authorities.
  • General regulatory requirements for the above-mentioned market.
  • Bio-waiver strategy