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We understand the complex and quickly evolving regulatory environment for Advanced Therapy Medicinal Products (ATMPs). We have an uninterrupted history of MHRA compliance dating back to 2004.
The regulatory framework for ATMPs is intended to facilitate the movement of these products across the EU, encourage a competitive market and assure the safety and health of patients.
The Directive 2001/20/EC of April 2001 outlines the regulations relating to good clinical practice in conducting clinical trials on medicines for human use. In 2014, the new Regulation EU 536/2014 on clinical trials on medicinal products for human use was accepted and will impact on ATMPs.
A new EMA draft guide on the quality, non-clinical and clinical aspects of gene therapy medicinal products was released for consultation in 2015 and is anticipated to be implemented in 2017. The purpose of this guideline is to update and consolidate the preceding guidance.
The Commission Directive 2003/94/EC of October 2003 outlines the principles and guidelines of Good Manufacturing Practice (GMP) relating to medicines for human use, and investigational medicines for human use. Draft guidelines for GMP of ATMPs were written and released for consultation in 2016 by the European Commission.
We have a long history of regulatory compliance
We operate in a highly regulated environment, governed by regulatory bodies such as European Medicines Agency and the Medicines and Healthcare products Regulatory Agency.
We undertook voluntary MHRA inspections in 2002 and 2003 before becoming licensed in 2004 and are proud to have demonstrated our Good Manufacturing Practice (GMP) compliance (as outlined by EU Directive 2003/94/EC) in every inspection since
We have several licenses including:
- MHRA MIA IMP (25224)
- MHRA ‘specials’
- GMP Quality Control (Veterinary)