Quality Systems

We perform work to the highest quality standards and consistently exceed our clients’ expectations. In order to meet the requirements of clients from different industry sectors we comply with EU and FDA regulatory requirements, company operating procedures and testing methods.  We also commit to continuous improvement and implementation of better processes and organizational efficiencies as well as train and support our employees so they can offer quality services.

Employees receive training in cGMP, standard operating procedures and laboratory techniques and methods. An independent quality assurance department reviews all data, notebooks etc.

Investigational medicinal products manufactured or imported are subject to full qualified persons release. The quality review process provides assurance of the quality system and the effectiveness of corrective and preventative actions (CAPA).  Routine internal and external quality audits for cGMP compliance assure that our quality systems are consistent with current industry standard.

Good Manufacturing Practice (cGMP)

We perform Formulation Development in compliance with the principles and guidelines of GMP as laid down in Commission Directive 2003/94/EC, by the Medicines and Healthcare Products Regulatory Agency (MHRA).  The Manufacture of Investigational Medicinal product and associated analytical procedures fully comply with annex 13 of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007.

Manufacturing equipment and laboratory instrumentation is subject to our comprehensive qualification process (IQ/OQ/PQ). Calibration, validation and preventative maintenance is independently monitored by Quality Assurance.

Our Investigational Medicinal Product Manufacturing facility has been inspected and approved by the Medicines and Healthcare Products Regulatory Agency (MHRA).