Who We Are
Fenton Fong, MSc.
Founder & Principal at xCellarate
More of my bio...
Hi there, my name is Fenton, thanks for visiting xCellarate's site!
I've been working in the regulated healthcare products industry for over 25 years. My career is focused on Pharmaceuticals and Biotechnology and has evolved to include other related industries such as Medical Devices, Natural Health Products/Dietary Supplements, and more recently legal Cannabis.
My passion and skills lie in three broad areas of regulated healthcare products: Manufacturing, Quality and Regulatory Affairs. It seems that everything I do and the projects that I get involved in all these years somehow always fall within these three areas.
I still remember the first time I came across the term "Biotechnology" way back in my undergraduate years, while conducting a scientific literature search in "the library stacks", for a term project. -ie. long before the internet age and digital downloads! Something stirred deep inside when I came across this term, it was a pivotal moment of discovery of career direction for me.
I started out working in a fine chemical production plant, then in life science R&D laboratories, getting my work published, and eventually obtained my MSc. My career expanded into biopharmaceutical product development and commercial manufacturing, followed by Quality Assurance and Regulatory Affairs interaction with Health Canada & US FDA. My career naturally evolved into industry consulting, I've had an interesting and varied career journey that continues to take me down new avenues.
I enjoy sharing my knowledge and experience with clients and helping them with problem solving, execution of complex projects, and providing value-added solutions. We learn and grow together, the relationships that I've built and continue to build along the way are at the core of my purpose.
Feel free to contact me, we hope that xCellarate may be of service to you!
Fenton Fong, MSc
Corporate career highlights which I bring to xCellarate's clients:
Provision of consulting expertise to over 75 different company clients representing numerous product brands
Clients & GMP projects based in Canada and worldwide (Cuba, China, Singapore, Malaysia, Peru, Nigeria, USA)
Conduct of numerous GMP Quality & Compliance Audits
Ground-up development and implementation of a QMS management system for a state-of-the-art sterile biopharmaceutical product production facility (Health Canada GMPs, USFDA cGMP and EU regulations for aseptic processing)
Member of technical team responsible for coordinating the design of cleanroom facility, procurement of major equipment and contractors for facility construction and facility commissioning.
CMC Technical writer & team member for a successful NDA submission and US FDA approval of a block buster parenteral biopharmaceutical product
Compiled regulatory filings and strategy for variety of product types
Delivery of numerous GxP Training courses