Ashok Panwar, PhD
Dr Ashok Panwar is an industry leader in Quality and Regulatory for Biopharmaceuticals, with over 30 years of experience serving humanity with quality drugs, vaccines, injectables and herbal products. He has served as Head of Global Quality & Regulatory for several top companies worldwide and has trained innumerable leaders in Quality and Regulatory. He is member of the Indian Pharmacopoeia Commission (IPC) Expert Committees, Member of GMP Technical Committee, Institute of Pathology (ICMR), New Delhi. Member of USP Expert Committee (Vaccines & Bio-similar) and Qualified Auditor.
His breadth of experience pans across CQA, Audit & Compliance, Remediation Plans & Compliance, QA, QC, AMV and Global Regulatory Affairs for API, API based Finished Products sterile and non-sterile (Injectable, Solid oral, liquid, soft gel, ointments), bulk antigens for vaccines, Vaccines (Oral & Injectable sterile), Biopharmaceuticals (Bio-similar) and Herbal products (DS & DP, POM).
He has successfully faced US FDA, EU, ANVISA (Brazil), TGA, WHO and ROW site audits. In all, have faced over 200 regulatory site inspections so far and performed over 100 plant audits as a part of Vendor Qualification, Regulatory Tox studies (non-clinical) CRO’s and CRO’s for Clinical Trials (Phase-I, II and III) in USA, EU, China and India.
Headed 7 years Global Regulatory Affairs Department for approval of NDA, ANDA’s, BLA, Vaccines, Bio-similars and NCE [Herbal Products] and, am having very sound knowledge of Global Regulatory Requirements.
Before moving to Industry Dr Ashok Panwar completed his Master and PhD degree in Analytical Chemistry from Indian Institute of Technology (IIT) Roorkee, India. He is an avid teacher who believes in transfer of knowledge rather to younger colleagues.
He has joined MedTherapy in alignment to its noble mission to make Cancer therapies more affordable and accessible. He is presently heading Quality as Senior Vice President and guiding the organization in aspects of Quality and Compliance