Regulatory Support

ISO 13485:2016 and ISO 9001:2015 Certification

STEMCELL operates a Quality Management System that is certified to the requirements of ISO 13485:2016 and ISO 9001:2015 for the following scope:

The design, manufacture, distribution and sales of In Vitro Diagnostic products and Research Use Only products, reagents and laboratory equipment. These research use only products are complemented by Services including contract assays, proficiency testing and training.

Our certificates can be downloaded below:

ISO 13485:2016
ISO 9001:2015

Establishment Licences

STEMCELL is a registered establishment with Health Canada and the FDA.

Supporting Your Compliance Needs

Under the Key Relationships Management Program, STEMCELL may be able to support the use of our products as ancillary materials (as defined under USP <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products) under an approved Investigational New Drug application (IND), Clinical Trial Authorisation/Application (CTA), Biologics License Application (BLA) or equivalent regulatory filing. Please contact us with your clinical inquiries; we’re here to help! We have successfully supported over 35 clinical trials around the globe, with the majority in the US.

What is cGMP?

cGMP stands for current Good Manufacturing Practices. GMP is a series of processes, policies, and controls making up a Quality Management System that assures the resulting manufactured product is safe and efficacious for its intended use. ‘Current’ signifies that although the regulations for GMP were put in place decades ago, compliance to these regulations must include current industry standards, science and technology. The compliance requirements of GMP extend through the product life cycle and include design, manufacture, testing, labeling and more.

As many of STEMCELL’s customers move into the translational space for cellular therapies, we are dedicated to supporting you using our products by following the qualification framework outlined in USP <1043>, Ancillary Materials for Cell, Gene and Tissue Engineered Products. Ancillary Materials / Raw Materials manufactured under cGMP is often not required for pre-clinical and early phase clinical trials - this may vary by region (for more information on the use of ancillary materials in cellular therapy, please refer to this whitepaper). STEMCELL manufactures Ancillary Materials / Raw Materials under a robust Quality Management System certified to ISO 13485, Medical Devices, which often demonstrates enough control to support pre-clinical and early phase clinical trials. Please contact us with your clinical inquiries; we are here to help!

Letter of Authorization (LOA) Request

To reference STEMCELL’s Drug Master File in your FDA application, please complete STEMCELL’s online request form for a Letter of Authorization (LOA).

Drug Master Files (DMF)

A Drug Master File (DMF) is used to provide detailed, confidential information about the manufacturing facility, processes, testing and storage of our products to the US Food and Drug Administration (FDA). STEMCELL can provide written authorization to the FDA to allow them to access this information in support of your regulatory submissions.

All information in the DMF is confidential.

STEMCELL has submitted DMFs for several of our catalog and custom products. Please contact our Regulatory Affairs team for a Letter of Authorization to cross-reference a DMF or to request additional information.