xCellarate & Associates is a trusted partner for GMP consulting solutions in the Pharmaceuticals/Biotechnology, Cosmetics, Natural Health Products, Medical Device, & Legal Cannabis industries
Manufacturing/CMC, Quality, Regulatory
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!
"Playing a value-added role in advancing life science technologies and bringing consumer health products to the market for our clients is xCellarate's core passion."
Managing Director & Principal
Here are recent projects for xCellarate:
2-month GMP remediation project for a cosmetic manufacturer
3-month GMP remediation project for COVID-19 product manufacturer
third-party internal audit of ISO13485:2017 accredited medical device company
GMP GAP assessment for Class I COVID-19 medical device manufacturing
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
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
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
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