Sue McGee, President
As one of the company founders, Sue brings more than 25 years experience in the pharmaceutical regulatory and compliance field to our clients. With a B.Sc. (Honours) in Toxicology (Biomedical emphasis) from the University of Guelph, her career path has included toxicology consulting for environmental and health-related projects and progressive regulatory affairs and quality control positions in the animal health industry.
Well-versed in knowledge of Canadian regulations and key regulatory contacts for a variety of products, Sue is able to successfully recommend regulatory pathways to our international and domestic clients. With excellent organizational and problem-solving skills, she has assisted clients with their drug, biologics, feed and veterinary natural health product clearances.
Sue is an active member of both the Drug and Biologics Committee’s of the Canadian Animal Health Institute (CAHI) and has served as chair of the Submission Quality & Compliance Subcommittee working directly with the Veterinary Drugs Directorate (VDD) to strategize improvements, enhance efficiencies and international harmonization and ensure reduced backlogs. She was also a member of the Steering Committee developing the “Low Risk Veterinary Health Products” (LRVHP) interim notification program with Health Canada.
In 2015, Sue was honoured to be the recipient of the CAHI “Recognizing It Leaders” award.
With a B.Sc. in Molecular Biology from Concordia University, Jeannine’s career path has included clinical/preclinical laboratory and quality control technical work, eventually leading to a supervisory position specializing in parenteral drug manufacturing, validation and training. This strong compliance background is continually complemented by GMP and total quality management training courses.
With strong QA and analytical background, Jeannine is able to provide clients with clear and concise interpretations of Health Canada’s Good Manufacturing Practices (GMP’s) and Drug Establishment Licence (DEL) requirements. With detailed precision, she works with clients to develop all necessary documentation systems to ensure both initial and continuing compliance.
Jeannine was one of the first individuals accepted by Health Canada to function as an off-site Canadian Quality Control Manager for a variety of smaller pharmaceutical companies from coast-to-coast, most of which she continues to work for today.
Denis holds a B.Sc. in Agriculture (Animal and Poultry Science) from the University of Guelph and a D.V.M. from the University of Saskatchewan. His career path led him to clinic experience in large and small animal medicine and eventually as a Veterinary Biologics Veterinarian with the Canadian Food Inspection Agency (CFIA), inspecting the fabrication, importation and distribution of veterinary biologics in Western Canada.
Well-experienced in HACCP and ISO requirements (ISO Lead Auditor), Denis has expanded his compliance expertise to the area of drug and natural health product GMP’s, Drug Establishment Licencing and Site Licencing for NHP’s. Denis has been a key individual for domestic and international GMP audits, GMP training and other compliance-related projects and has had the opportunity and privilege to inspect, as an approved Health Canada 3rd party auditor, international manufacturers of OTC products for GMP compliance.
Denis is an active member of the College of Veterinarian of British Columbia (CVBC), the Canadian Veterinary Medical Association (CVMA) and the Canadian Veterinary Reserve (CVR).