Malini Batheja
VP Pharma R & d Cmc Regulatory at Eyenovia, Inc
Based in New York, United States
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Seniority
Vp
Department
Research & Development
Location
New York
Industry
Pharmaceutical Manufacturing
Company size
15
Contact information
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m•••••••@eyenovia.com
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Background
About Malini Batheja
Twenty-five years of managerial experience in research and development in pharmaceutical companies, including managing CMO activities worldwide (China, India, Europe, and US). Responsible for starting up analytical labs in three companies and supervising 25-30 chemists in different organizations. Authored the CMC section for 5 NDAs and 25 ANDAs, including PAI inspections for FDA, EMA, and Health Canada. Experience in many dosage forms Radiopharmaceutical, Ophthalmic, Tablets, Nasal, Liquids/Semi-solids, Chewing Gum, Ointment, Suspension, injectable, Biosimilars, peptides, proteins, gene and cell therapy.
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