Who We Are

Fenton Fong, MSc.

Founder & Principal at xCellarate

•30 years of combined corporate and consulting experience in Pharma, Biotech, NHP, Cosmetics and related industries.

•Execution of GMP consulting projects in China, Malaysia, USA, Nigeria, Cuba, Peru

•ISO9001:2015 certified Lead Auditor

•PDA Journal Editorial Board member

John Simon, BSc., RAC, CQA, RQAP-GLP

Senior Associate

•30 years of experience in Pharma, Biotech, Med Device and related industries in Alberta, 18 years as a consultant in Quality Management and Regulatory Affairs

•Certified Quality Auditor through the American Society for Quality. RAC Certification through the Regulatory Affairs Professional Society. RQAP-GLP Certification through the Society of Quality Assurance

•BSc (Biological Sciences), University of Alberta, 1991

Marvin Cervantes

Senior Associate

•Product development and commercialization professional with 25 years of experience. Led and managed implementation in design and development, Quality Control and Regulatory Affairs for Medical Device, Natural Health Products, and therapeutics.

•Certified ISO13485 Lead Auditor, ISO 9001 Lead Auditor

Bruce Girton, MSc.

Senior Associate

•32 years experience in small-molecule pharmaceutical development, with emphasis on analytical chemistry and quality control, including extensive experience with multi-functional CMC teams.

•Managed diverse programs from target selection/validation through clinical development and delivery.

•Subject matter expert in pharmaceutical analysis, including method development, method validation and method transfer, physical and chemical characterization of drug substances and reference standards, impurity profiles of drug substances and drug products, and stability studies.

•Versatile, innovative, productive and goal-oriented researcher, recognized for excellence across multiple disciplines, able to recognize and resolve technical, quality, regulatory, and organizational challenges encountered by pharmaceutical organizations.