Regulatory Affairs Services

Pharmaceutical, Medical Devices, Laboratory Equipment and Reagents Regulatory Affairs Services

Prodigy Healthcare’s regulatory affairs consultants assist companies in planning and managing their pharmaceutical and medical product development programs and regulatory requirements.

To speed up market access for your medicinal, Can we use healthcare instead of therapeutic? Products you need to ensure strict adherence to all regulatory requirements. Our regulatory affairs services help you explore the shortest route and timeframe to put your products on the market safely (or in a regulatory-compliant way)

  • Dossier/submission preparation or review and filing
    • Regulatory classification of products across different jurisdictions
    • Follow-up until complete registration with the regulator
    • Follow-up of Laboratory testing
    • Smooth transition of Local Technical Representative (LTR) mandates to the distributor of choice.
  • Provision of LTR service if the Marketing Authority Holder (MAH) would like multiple importers/distributors.
  • Development of a regulatory strategy for the product’s life cycle
  • Facilitate interaction with regulatory agencies, such as in meetings and conference calls, negotiations during development stages, submissions and submission approval process
    • Liaison with regulatory agencies on regulatory, Chemistry, Manufacturing and Controls (CMC), clinical and toxicology matters
    • Respond to regulatory agency questions
  • Consultancy on medicinal products in development, generics, biosimilars, bibliographic submissions and orphan drugs
  • Strategic regulatory advice
  • Post Registration support with Pharmacovigilance and compilation of Periodic Safety Update Reports (PSUR) from the market