Chief Executive Officer & Chairman
Dipak Doshi is the Chief Executive Officer of Protocol Link. Mr. Doshi has over 30 years of experience in the pharmaceutical, biotechnology, and medical device industries. He has extensive experience in parenteral drug manufacturing, cGMP compliance strategies, cGMP documentation systems, cGMP compliance audits, PAIs, CAPA system development, TrackWise validation, validation master plans, process validation, critical system validations, equipment qualifications (IQ, OQ, PQ), computer and software system validation, ERP system (SAP, MAPICS, J.D. Edwards) validation, cleaning validation programs, and CDER/CBER submissions.
Mr. Doshi has held several senior-level management positions in major pharmaceutical companies, directing development and implementation of cGMP compliance strategies and initiatives in support of marketed NDA products. He has performed NDA/ANDA gap assessments, developed product specifications, and written SOPs. Mr. Doshi has subject-matter expertise in APRs, site transfer strategies, process validation programs, personnel training, product assessments, FDA review and inspection liaisons, vendor audits, quality and technical agreements for contract manufacturing, product complaint investigations, and product recall management reviews. Additionally, he has managed audits covering drug manufacturing and testing sites throughout the USA, Europe, and Asia. Mr. Doshi received his M.S. degree in Microbiology & Genetics from Illinois Institute of Technology located in Chicago, Illinois, USA, and another M.S. degree in Industrial Microbiology from Gujarat University in India. Mr. Doshi is affiliated with PDA, ISPE, ASQ, and NRM.