Minakshi Singh PhD, DABT
Associate Director @ Lupin Pharmaceuticals
About
A research and development professional with experience in preclinical investigative and regulatory toxicology. Non-clinical development through the design, management, and regulatory requirements of specific non-clinical safety projects. Conversant with tools for insilico analysis, invitro and invivo toxicity testing, risk assessment for qualification of drug related impurities, nitrosamines and extractable and leachable. Leading the outsourcing and monitoring of non-clinical safety studies. Regulatory dossier preparation, and interactions with authorities. Specialist: Regulatory and investigative toxicology, insilico, safety pharmacology, IND candidate development, 505 (b) (2), Risk assessment, Impurities, Nitrosamines, Leachable/extractable, GLP compliance
India
Pune/Pimpri-Chinchwad Area
Pharmaceuticals
GLP, Drug Discovery, Drug Development, Pharmacokinetics, Toxicology, Regulatory Submissions, Drug Metabolism, CRO
Experience
Associate Director
Lupin Pharmaceuticals
Assistant Director
Lupin Pharmaceuticals
Scientist
Lupin Research Park
Research Associate
Lupin Research Park
Pre-Clinical Toxicology
Minakshi Singh PhD, DABT's Contact Information
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