Quality Assurance and Regulatory Compliance

Angel Biotechnology is totally committed to quality, current Good Manufacturing Practice (cGMP), customer service and continuous quality improvement. The company has a dedicated Quality Unit which monitors all aspects of quality and cGMP Development and Manufacture, including Qualified Person (QP) certification of product.

The company has a quality management system to meet the requirements of Good Manufacturing Practice (2003/94/EC) for the manufacture of clinical trial supplies and also operates under ICHQ7a for the manufacture of Active Pharmaceutical Ingredients.

The Pentlands Production Facility is MHRA (Medicines and Healthcare Products Regulatory Agency) approved under directive 2001/20/EC for the manufacture of Investigational Medicinal Products (IMPs).

This licence gives authority for the manufacture of biological active substances under contract for EU clinical trials demonstrating compliance in accordance with the European Union (EU) Clinical Trials Directive. The licence also includes manufacture of cellular therapies and stem cells.

As well as having a license from the MHRA, the facility at Pentlands Science Park is licensed by the Human Tissue Authority (the HTA) which regulates the storage, use and disposal of human tissue in the UK.