Our Services

Regulatory Affairs Services

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

Prodigy Healthcare’s regulatory affairs consultants assist companies to plan and manage their pharmaceutical and medical product development programs and regulatory requirements.

To speed-up market access for your medicinal Can we use healthcare instead of medicinal? 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)

Pharmaceutical Regulatory Affairs Services:

  • 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) mandate to the distributor of choice
  • Provision of LTR service in the event the Marketing Authority Holder (MAH) would like multiple importers/distributors
  • Development of 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

Learn More About Prodigy Healthcare

Contact us to learn more about our capabilities and to discus how we can make a difference together.

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