Look to xCellarate for GMP consulting solutions in the Pharmaceuticals/Biotechnology, Cosmetics, Natural Health Products, Food, & Legal Cannabis industries
Manufacturing/CMC, Quality, Regulatory
"Playing a value-added role in advancing life science technologies and bringing consumer health products to the market is a core passion."
Managing Director & Principal Consultant
"I found Fenton very easy to work with, flexible on ideas and implementation, provided expertise on subject matter, and delivered results according to plan. I would work welcome future opportunities to work with Fenton again."
Ingo Beck, -Director Of Manufacturing at Resolution Bioscience
Consulting expertise in three broad areas within the regulatory frameworks of Health Canada, US FDA and other jurisdictions:
-Product Development & CMC Manufacturing Support,
Project management & value-added consulting solutions to complex projects and Technology Transfers.
Deep understanding of GMP application, GMP remediation and the challenges of applying the requirements from one client to the next.
GMP and Quality Systems auditing; I am an accredited ISO 9001:2015 Lead Auditor.
Access and leverage to broad knowledge and expertise. xCellarate is networked or partnered with wide variety of industry professionals, subject matter experts, service providers and vendors.
If you want to dive deep to find out more technical details about xCellarate's consulting expertise, just click on the link immediately below!
"Fenton is exceptionally organized, diligent, capable and knowledgeable about bioprocesses and their application for Industrial and Pharmaceutical applications. ...I unreservedly recommend Fenton for any position requiring detail oriented high quality work. "
Rob Forsyth, -Instructor at BCIT
Here are recent projects for xCellarate:
GMP GAP assessment for Class I COVID-19 medical device manufacturing
Preparation and submission of Cosmetic Notification Form registration for over 30 products
Diligent liaising with EU Responsible Person entity to successfully obtain EU Notification of 12 cosmetic products
Matching suitable service providers of laboratory testing, 3PL distribution, cosmetic manufacturing for client
Spec’ing and procurement of packaging equipment for approved topical product
Sourcing a suitable supplier for excipient ingredient for capsule product formulation
GMP GAP analysis of OSD/powder dosage forms manufacturing facility to develop action plan for revalidation and DEL renewal.
Sourcing suitable contract manufacturer for Covid-19 hand sanitizer production
Regulatory oversight for label content development of 9 cannabis topical products for retail sale in USA
Determination of cosmetic product viscosity for design of mixing equipment
GMP GAP analysis of existing manufacturing facility for retrofit and upgrades for cannabis extraction.
Develop URS for manufacturing equipment, seek and review tender bids
GMP audit of DIN and cosmetic manufacturing facility for extension as approved foreign manufacturer in client DEL
GMP due diligence audit of 3PL facility for clinical trial materials distribution
Successful INCI registration of a new cosmetic ingredient
“…I have found Fenton to be very professional, organized and a pleasure to work with. xCellarate was brought in to our company, Yield Growth, as a Senior advisor to assist us with Health Canada Regulations. As a Director of Product and formulator for the company, Fenton has assisted me in many areas with his expertise. … I feel very fortunate to work closely with him and his knowledge which has enhanced my skills beyond production.”
Bhavna Solecki, -Director Of Product Development & Formulations, Yield Growth Corp.
Hi there, my name is Fenton, thanks for visiting my site!
I've been working in the regulated healthcare products industry for over 25 years. My career started in Pharmaceuticals and Biotechnology, and has evolved to include Cosmetics, Foods, 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, I hope that I may be of service to you!
Fenton Fong, MSc
Corporate Career Highlights
Corporate career highlights which I bring to my clients:
Provision of consulting expertise to over 75 different company clients representing numerous product brands
Clients & 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
"Fenton worked with me in several different projects. In one project, he was in a cross-functional team with me on a large GMP remediation project to rescue a DIN product contract manufacturer from imminent forced closure by Health Canada. Playing a key role as the acting Production Manager, Fenton implemented several remediation measures including but not limited to: helping develop a strategic process validation approach, equipment and facility remediation, overseeing and witnessing destruction of recalled product, overseeing redesign of SOP program, and delivering GMP training.
In another project, Fenton worked with me to conduct a GMP due diligence inspection of aseptic processing activities for a parenteral product preparation, located in a foreign country. He was very thorough in his work detail, he wrote the final report with all of our findings and recommendations. The report was well received by both the client and the foreign Government ministry. I find Fenton to be a pleasure to work with. He is humorous, intelligent, productive and I would highly recommend him for any role associated with technology transfer, manufacturing operations management or validation."
Ravi Joshi, -Past President PharmEng Technology, Advisory Board Member PE Pharma