Qualified Person Certification Our QPs and your clinical trials in Europe & EEA
A Quality Assurance Manager at UK-based pharmaceutical services company, Biotec Services International Ltd, has gained Qualified Person (QP) status.

Following 10 years in the pharmaceutical industry, Tristram Evans is now a European registered QP after completing three years of professional training and examinations to attest his knowledge of the sector and can now help you with Qualified Person Certification and QP services for release of IMP and clinical trials into Europe and the EEA.

With a wealth of experience performing audits to ensure GMP compliance, Tristrams industry recognised qualification will enhance Biotecs QP consultancy services as he is now qualified to certify all commercial products or investigational medicinal products (IMPs) entering into clinical trials within the European Union.

With his qualification, Tristram will be working with Biotecs international clients to confirm that the IMP has been manufactured in accordance with Good Manufacturing Practice (GMP) guidelines and other relevant clinical trial authorisations.

After graduating with a Chemistry degree from University of Wales, Cardiff, Tristram joined Penn Pharmaceuticals as a Quality Control Analyst. This was followed by the position of Quality Control Analyst at Norgine, before moving onto a role as Quality Assurance Auditor. Tristram then joined Biotec in 2007 as Quality Assurance Manager.

On achieving this official recognition, Tristram said: This was very important for my professional development. Biotec has invested a lot of time and effort into my training and Im truly grateful for their support. Gaining this qualification comes at an important time for the company as we and our international client base continues to grow. I am looking forward to working with clients to facilitate the smooth importation of products into the EU.

Biotec has a team of highly experienced QPs who work with clients from across North America, Israel, Asia and within the EC/EEA, helping to facilitate the smooth importation of IMPs into Europe for use in clinical trials both within the EC/EEA and other regions.

Keren Winmill, CEO of Biotec Services International, said: Tristram has worked with us for a number of years now so we knew that he had the ability to succeed as his experience and regulatory knowledge is excellent. Were naturally pleased for him on a personal level as he put so much energy into his training, but also in a professional capacity as it will enhance our growing QP consultancy services.

The role of the QP is undoubtedly becoming more difficult. New IMPs, such as Advanced Medicinal Therapy Products, are pushing the boundaries in terms of technological and medicinal development. Biotec is closely involved in the management of clinical trials involving these therapies and we are confident that Tristram, along with our existing team of registered QPs, are the best in their fields and can work with these increasing pressures for our clients success.

You can find out more about our QP Certification Services here