The Experts Behind Radical Pharma
A senior team with deep expertise across Canada, the United States, and Europe — delivering practical, high-impact regulatory and quality solutions wherever you need them.
Umesh Panchal
Umesh is the Founder of Radical Pharma Consultancy Inc., bringing over 20 years of experience in Quality Assurance and Regulatory Affairs across the pharmaceutical industry. With a career spanning Mylan UK, Mylan Canada, and Auro Pharma, he has deep expertise in GMP/GxP compliance, FDA and Health Canada regulatory frameworks, and quality system development. Umesh is passionate about helping startups and mid-sized companies build robust compliance foundations and navigate complex regulatory environments with confidence.
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Michelle Mc Guinness
Michelle is the Founder of Pharmaceutical Compliance Partners, LLC, with extensive expertise in Regulatory Affairs, Quality Assurance and Commercial Compliance. A former Senior Director at AstraZeneca, she has held leadership roles at Janssen, Mylan, Sanofi, and J&J. She holds an MSc in QA/Regulatory Affairs from Temple University and has been recognised with the FDA Commissioner's Special Citation for her contributions to the HL7 Structured Product Labeling standard.
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Jitendra Patil
Jitendra is a UK-based Regulatory Affairs Consultant with over 15 years of experience across the British and European pharmaceutical industry. He has held senior roles at AstraZeneca, Pfizer, GlaxoSmithKline, MSD, UCB, and Dr Reddy's, specialising in CMC regulatory strategy, biologics drug development, EU/UK MAA submissions, and post-approval lifecycle management. He holds an MSc in Pharmaceutical Science from Kingston University, London.
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