Regulatory Affairs Services

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

Prodigy Healthcare's team of regulatory affairs consultants specializes in guiding companies through the intricate landscape of pharmaceutical and medical product development programs and regulatory requirements.

To expedite market access for your healthcare products, strict adherence to regulatory guidelines is paramount. Our regulatory affairs services are designed to streamline this process, ensuring your products reach the market swiftly and in full compliance with regulations.

Our services include:

• Preparation or review and filing of dossiers/submissions
• Regulatory classification of products across different jurisdictions
• Follow-up until complete registration with the regulator
• Oversight of laboratory testing
• Seamless transition of Local Technical Representative (LTR) mandates to the distributor of choice
• Provision of LTR service for multiple importers/distributors, if desired
• Development of a regulatory strategy for the product’s life cycle
• Facilitation of interaction with regulatory agencies, including meetings, conference calls, and negotiations
• Liaison with regulatory agencies on regulatory, Chemistry, Manufacturing and Controls (CMC), clinical, and toxicology matters
• Response to regulatory agency inquiries
• Consultancy on various aspects, including 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

With Prodigy Healthcare's regulatory affairs expertise, you can navigate the regulatory landscape with confidence, ensuring timely market entry and ongoing compliance.