Over thirty five years of experience in Clinical Pharmacology, Pharmacokinetics, Global Clinical Trials, Clinical Data Management. Conducted and managed over 1000 Bioequivalence studies for Europe, US, Brazil and others. Former Founder Director of a leading CRO, Lambda Therapeutic Research and held senior leadership positions in Operations, Strategic Business and Organizational Development in Jubilant Clinsys. Fifteen years in generic drug development for EU,US, Australia at Ranbaxy Laboratories and later thirteen years in CRO industry. Leadership position in integrated Drug Discovery and Clinical Development.Holds honorary positions in various professional organizations and recipient of several leadership awards.
A pharmacist with close to 25 years of experience in the Pharmaceutical Industry. Primary area of expertise has been in Generic Pharmaceuticals, where she provides Strategic, Regulatory and Scientific Consulting to clients interested in catering to the US, EU, Australia, Canada and other International Markets. Extensive experience in Research & Development, Scale-up and Technology Transfer, Manufacturing, Project Management, Global Regulatory Affairs and Compliance covering all activities from ideation to execution of launch of products. Conducted Quality Audits, Prepared Organization for inspections as well as supported cGMP inspections and approval of manufacturing facilities. She has experience in doing Gap Analysis and Conducting Due-Diligence for Acquisitions and Strategic Alliances.