Chirag Shah
Director @Transpire Bio
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WORK HISTORY
Director @Transpire Bio
US
EDUCATION
Gujarat University
M.Pharm., Pharmaceutics and Pharmaceutical Technology
SKILLS
ABOUT CHIRAG SHAH
25+ years of experience in leading pharmaceutical drug product development and drug-device combination product delivery systems. Submitted over 150 pharmaceutical drug applications, including NDAs, 505(b)(2) submissions, complex generic ANDAs, and MAAs across the EU and UK.Profound understanding of pharmacokinetics, in-vitro bioequivalence studies and in-vitro dissolution. Demonstrated expertise in technology transfer from laboratory scale to commercial manufacturing, including scale-up, process validation, and successful global product transfers between manufacturing sites for complex dosage forms.Worked with reputed pharmaceutical companies like Apotex Inc, Dr.Reddy\'s Labs, Torrent Research Centre, Jubilant Organosys Ltd, Zydus Cadila Limited, Alembic LimitedCore Competencies :• CMC Development (ANDA/NDA)• Clinical (Bioequivalence) Studies• GxP Compliance & Building ‘quality culture’• Manufacturing Process Optimization, Scale up and Process Validation• Intellectual Property Protection • Risk Identification and mitigation
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