Naseem Ahmad Charoo

Dr. Naseem Ahmad Charoo is an accomplished pharmaceutical development professional with over 25 years of experience in Formulation Research and Development, Lean Manufacturing, Validation, Regulatory Affairs, Pharmacokinetics and Pharmacodynamics, Quality Control and Quality Assurance, Project Management, Green Field Investments in Pharmaceutical Manufacturing, Pharmaceutical Compounding, Business Development, Staff Training and Cross-functional Leadership.

He is Presently serving as Chief Operating Officer of Wissen Healthcare LLC, Dubai that provides turnkey solutions to pharmaceutical, dietary supplement, medical device, cosmetics, and biotechnology industries in the design and successful execution of development programs.

He has worked in South America, Europe, India, Africa, South-East Asia, and the Middle East over the course of more than two decades. Dr. Naseem has held senior managerial roles with Ranbaxy Laboratories India, LaGray Chemical Company Ghana, Xepa Soul Pattinsons Malaysia, Sauad Farmaceutica Brazil, Blue Nile Pharma Sudan, Neopharma LLC Abu Dhabi, Adcan Pharma Abu Dhabi, Aramed LLC, Dubai, and QLife Pharma Qatar, handling all aspects of pharmaceutical development and manufacturing.

Additionally, he is acting as a technical consultant to the United States Pharmacopeia to oversee the development of a technical guide for dispersible tablets for the PQM+ program that aims to enhance local pharmaceutical manufacturing capabilities in developing countries to meet objectives set in the WHO Millennium Development Goals.

He is a member of the Focus Group on BCS-Based Biowaiver monograph development [formerly supported by International Pharmaceutical Federation (FIP) and WHO)] to support the pharmaceutical industry in developing countries. The overall aim of the program is to provide a risk assessment – Will application of the BCS-Biowaiver (and hence approval without running clinical studies to prove bioequivalence) be risky for the individual patient and/or for public health? Biowaiver monographs for more than 50 drug products have been published thus far.

Dr. Naseem has a proven track record of successfully leading pharmaceutical companies through the WHO prequalification process. He has developed and filed over 100 ANDAs with the USFDA, EMA, ANVISA, WHO prequalification, SFDA, ASEAN and in other regulatory jurisdictions. Naseem holds a Ph.D degree in Pharmaceutics and has published over 70 research articles and 20 book chapters.