Principals

Peter holds a Bachelor of Science degree in Pharmacy from the University of Toronto.  He has extensive experience in the area of drug approval both in industry and government.  Following early experience in the pharmaceutical industry, he spent over 30 years at Health Canada specializing in the CMC area.  He was Director of the Bureau of Pharmaceutical Quality responsible for the chemistry and manufacturing evaluation and approval.  Peter’s international experience includes the ICH Expert Working Group (Quality) from 1991-1996, the USP Expert Advisory Committee on multi-source drugs, development of an international standards based electronic submission platform, and a global chemistry and manufacturing dossier format which formed the basis for the ICH Common Technical Document.

Robert holds a Bachelor of Applied Science degree in Chemical Engineering from the University of Ottawa.  While working as a consultant Robert has prepared numerous CMC summary documents and data packages for regulatory filing,  provided scientific advice on CMC issues, and prepared expert reports and detailed reviews of CMC data in submissions.  Robert also has experience in the preparation of CS-BE templates.

Scott holds a doctoral degree in Biology from Carleton University.  While working as a consultant Scott has prepared numerous CMC summary documents and data packages for regulatory filing, provided scientific advice on CMC issues, and prepared expert reports and detailed reviews of CMC data in submissions.  Scott also has considerable experience in the preparation of Biological submissions for regulatory filing.