Areas of expertise: Pharmaceutical GMP/CMC Manufacturing, Process/Product development, Quality Management, Technology Transfer, Technical Writing.
For nearly 30 years, Fenton has worked in the Pharmaceutical, Biotechnology, and other Healthcare related industries. His experience and expertise spans Manufacturing, Quality & Regulatory. He has served Quality Assurance Management roles at an OTC Contract Manufacturer and for a state-of-the-art biopharmaceutical (sterile product) manufacturer. He has participated as an integral team member in CMC development and FDA approval of a blockbuster parenteral drug product. He has also been integrally involved with design, construction and commissioning of sterile product and other clean room manufacturing facilities. Fenton has engaged in more than 100 GMP and QMS remediation projects, domestic & international. He is a ISO9001:2015 certified Lead Auditor and serves as an Editorial Board member (JPST) for the Parenteral Drug Association (PDA).
Fenton is the Founder, Managing Director & Principal at xCellarate & Associates. xCellarate is based in Vancouver, British Columbia, Canada. We are a consortium of Associate consultants with seasoned career experience, serving clients in Canada/USA & Asia. xCellarate is a trusted partner for providing consulting solutions to complex challenges in:
- CMC Manufacturing/Product development (biologics, small molecule, aseptic processing)
- Quality (QMS/GMP development & remediation, audits)
- Regulatory (filings, applications, strategy)
- Provide solutions to the Biotech/Pharma/Medical Devices/NHP/legal cannabis industries