GMP
Here at AMSBIO we understand the importance of GMP compliance for a seamless pre-clinical to clinical transition. This page is here to help as you optimise your strategy for transition from bench to bed-side. We can ensure that you meet your regulatory requirements by providing a secure supply of high quality and reliable, GMP-compliant materials for your Advanced Therapy Medicinal Products (ATMP) manufacturing. We also offer support for your change control procedures and quality risk management.
In this section, you will find links to all the information you need on how AMSBIO can help facilitate your manufacturing process. Access our list of GMP-compliant products and services, our Guide to GMP, a link to our 'Manufacture' section of our Expanded Stem Cell Synergy, and a link to our Custom Services area, which have GMP compliant options to suit your needs.
We're also always available to talk about your requirements: just email us on [email protected] and see what we can do for you.
FDA Guidelines for C> Manufacture
See an overview of FDA guidelines for C>, focusing on key regulatory steps to ensure safe, efficient development and pathways to accelerate approvals.
Discover our range of high quality, GMP-compliant products & services below
Our GMP-compliant products
Guide to GMP
GMP products for Expanded Stem Cell Synergy
Custom sevices
Supporting your GMP needs
- FDA-registered Drug Master Files available, for streamlined clinical translation.
- AMSBIO is ISO 9001 certified in both the UK and The Netherlands, allowing you to have confidence in your GMP supply chain.
- Robust quality control processes and trained staff to meet regulations.
- Ensured traceability: all required documentation available upon request.
Quality Management
To demonstrate our commitment to Quality Management, AMSBIO has been continuously ISO9001 certified in the UK since 2011, and the Netherlands since 2024.