Designing Operation Manuals for Medical Devices
Thank you for your interest in Freyr’s Webinar Series (FWS). The webinar on, “Drug Importation to India- A Regulatory Blueprint,” was successfully concluded on June 17, 2021. Here is an archived version for your perusal.
What Was It All About?
In this webinar, our Indian Regulatory experts - Dr Ghulam Moinuddin and Michael Lambell have elaborated:
- Overview to Indian Pharma Market & CDSCO/DCGI
- Why India? (potential of pharma business in Indian market)
- India on Priority: Top 5 Global Pharmaceuticals/Bio-Pharmaceutical MNCs
- India-Regulatory pathway: Marketing Authorization Approval/Import Permission; Registration of Manufacturing Facility; Import License
- Clinical Trial Approval
- Rationale for New Drug Approval and Requirements
- Authorized Indian Agent and Warehouse: Overview
- Regulatory Challenges Faced by a New Applicant
- Success Story
As a continuous practice, Freyr is destined to organize more webinar sessions related to Regulatory aspects of Life Sciences. We presume that you would like to be a part of all those sessions. If yes, let us have an opportunity to inform you about our next session.