Director

Dr. Etse is a pharmaceutical scientist with several years of work experience in the pharmaceutical industry in the United Stats of America (USA) where he has led and supervised drug product development teams across different geographical locations and times zones. Dr. Etse has extensive knowledge in technology transfer activities that are required for the transfer of analytical and manufacturing processes from one global project team to another in accordance with current Good Manufacturing Practices (cGMP) for drug product (DP)/ drug substance (DS) analytical development and DP manufacturing operations. Dr. Etse has a broad-based experience conducting pharmaceutical Due Diligence reviews to identify potential asset investment opportunities and managerial and administrative responsibilities overseeing the development, planning and execution of Drug Product(DP)/Drug Substance (DS) Analytical and DP formulation development activities. Dr Etse's experience includes studies required for setting process control limits for DP manufacturing processes, specifications limits for DP and DS, stability testing programs for establishing Shelf life/Retest periods for DP/DS and HPLC method development/ validation experiments for investigational drug products. Additionally, Dr. Etse has had many years of regulatory dossier review activities to assure compliance with the latest ICH requirements (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) and as well experiences in the interactions with a number of Global regulatory authorities [i.e., US Food and Drug Administration (FDA), UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), Australia’s Therapeutic Goods Administration (TGA), Brazil Health Authority (ANVISA), Japan Pharmaceutical and Medical Devices Agency (PDMA), and China National Medical Products Administration (NMPA)] to assure prompt response to Health Authority questions following drug product regulatory dossier submissions for human medicine use approval requests. Dr Etse is the co-author on a number of peer reviewed scientific publications in drug product research and is the contributing author of two book chapters on the topics of Novel Dosage Form Analysis and the role of High-Performance Chromatography (HPLC) in Technical Transfer and Manufacturing. Dr Etse is an avid sports enthusiast and enjoys watching American Football, Soccer, Tennis, Basketball and Track/Field Sprint event s in his free time. Dr Etse loves to travel to visit museums of natural history to learn about different cultural practices and heritage of d ifferent countries..