Engaged with health-regulated industries since 1999

xCellarate & Associates is a trusted partner for GMP consulting solutions in the Pharmaceuticals/Biotechnology -Cell &Gene Therapy, Medical Device, Natural Health Products & Legal Cannabis industries

Manufacturing/CMC, Quality, Regulatory

xCellarate's Expertise

Product Development & CMC Manufacturing Support


QA/QC

Regulatory Affairs

The benefits of working with us

xCellarate provides consulting expertise in three broad areas within the regulatory frameworks of Health Canada, US FDA and other jurisdictions:

  • Product Development & CMC Manufacturing Support,

  • QA/QC,

  • Regulatory Affairs

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."

Fenton Fong

Managing Director & Principal


Recent Projects

Here are recent projects for xCellarate:

  • CMC Sterile Drug Product manufacturing process development/Tech Transfer & liase with CDMO

  • CMC project management for Clinical Trials drug product supply in 3 countries

  • 21 CFR Part 210/211 Gap Analysis of a CAR-T cell CDMO

  • 21 CFR Part 1271 Gap Analysis for CAR-T cell manufacturing process

  • 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