Peter Tomlinson, Ph.D., MBA
TCG Consultant
Dr. Tomlinson has been involved in the pharmaceutical industry for his whole career. Experience includes quality assurance, operations and general management in pharmaceutical manufacturing operations. He was involved in implementing programs to ensure a Canadian based cream and ointment manufacturing to FDA requirements and led the organization through it first FDA preapproval and general compliance inspections. Dr. Tomlinson was also responsible for the preclinical and clinical development of a revolution drug delivery technology improving the delivery of existing cancer therapeutics.
Dr. Tomlinson started consulting in 2000 based in Toronto focused on running CMC programs for small biotechnology and pharmaceutical companies taking new products into clinical trials. He has been a QP under EU regulations since 1987 and is also heavily involved in managing the importation of clinical supplies into the EU for products manufactured in North Ameria.
At Upjohn, Sandoz, and Glaxo, Dr. Tomlinson served in various roles in Quality Assurance and new product development. At Taro, he served as General Manager, responsible for the management of a pharmaceutical manufacturing operation with a staff of 200. Then at Supratek Dr. Tomlinson served as President, responsible for all operations associated with the development of a new drug delivery technology. Now, as a consultant, he is involved in advising companies on the development of new products and technologies.
Key project interests include running CMC programs for small molecules, GAP analysis audits of GMP facilities to the requirements of the FDA and EU, and managing the process for importing of clinical trial supplies into the EU.