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Session 1: The Regulatory Maze: Mapping Pathways to India, EU, and US Market Access
Session Chair(s)
Sinto Poulose
Director
IQZYME MEDTECH PVT. LTD , India
Session Focus: A practical navigation session on US FDA, EU MDR, and India’s CDSCO regulatory routes—how to choose the right pathway, avoid common and avoidable delays, and build a regulatory strategy aligned with your product type, risk class, and target market timelines. Expect concrete do’s and don’ts from real submissions, approval journeys, and market-entry playbooks across mature and emerging markets.
Speaker(s)
Aseem Sahu
CDSCO Office, India
Deputy Drugs Controller
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