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The Future of

Bio/Pharmaceutical Analysis

Archana Bahuguna

Dr. Archana Bahuguna

Regulatory Compliance Specialist

Regulatory Compliance SME

Dr. Archana Bahuguna is a professional with a career spanning over two decades in pharmaceutical companies – Unichem, Zydus Cadila, Merck KGaA, Pfizer, Accutest, KPMG, Raptakos Brett.

She has extensive global experience in leading Analytical R&D teams supporting development programmes (Phase 1 to Phase 3) for drug substances & drug products comprising diverse portfolios of NCEs/Generics & Quality Control teams supporting commercialization of drug substances, drug products. She has led several successful regulatory inspections in her professional assignments as an Analytical & Quality Control SME with regulators across the globe.

Archana has led cross-site, cross-functional teams contributing to successful development programmes, technology transfers, regulatory inspections, registration & commercialization of drug substances & drug products across geographies comprising US, EMEA, APAC & Latam.

She actively contributes as an Expert in Indian Pharmacopoeia Commission Scientific body’s Expert committees in the Expert Working Groups (EWGs) of Indian Pharmacopoeia under the aegis of Ministry of Health & Family Welfare of Government of India.

Dr. Bahuguna is

  • A certified Lean Six Sigma Green Belt (certified by Quality Council of India, Ministry of Commerce &Trade, Govt of India.)
  • Member of Analytical, Microbiology Quality Control Working Group of European Compliance Academy.
  • Life Member of Chromatography Society of India, actively involved as a Speaker in the various Webinars, Symposia conducted by the society
  • Visiting faculty at SIES Institute of Chromatography &Spectroscopy, Navi Mumbai.
  • Serves as a Member on Board of Studies, Dept of Chemistry, SIES College, Mumbai.
  • Actively engaged in conducting training Programmes for Industry, Academia, Regulators.

Dr. Bahuguna obtained her Ph.D. in Analytical Chemistry from University of Mumbai with specialization in Pharmaceutical Analysis & a Master’s in Organic Chemistry from University of Mumbai (University Gold medalist)

She has been the recipient of numerous Awards during her Academics & has also been recognized for her Professional contributions, a few among them include:

  • Featured amongst Asia GCC Iconic Women Leaders, is the recipient of Asia GCC Iconic Women Leader Award in Pharmaceutical Quality Control.
  • Women Super Achiever Award for Excellence & Leadership in Pharmaceutical Quality Control.
  • Most Trusted Women Leader Award for Excellence & Leadership in Pharmaceutical Quality Control.
  • India’s Most Dynamic Women Leader in Pharmaceutical Quality Control
  • Dr. K.A. Hamied’s Chemistry Prize at the M.Sc. degree exam (Sponsored by Cipla Ltd.)

Publications:

Lean Laboratories- The future of SMART Pharma Operations, Cutting Edge, March 2022.

FDA 483s – Impact on Pharmaceutical Manufacturing, Cutting Edge, March 2023.