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
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,
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 products to the market for our clients is xCellarate's core passion."
Managing Director & Principal
Here is a sampling of recent projects that the xCellarate team has engaged with:
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