Biotec Services International Limited - Pharmaceutical Outsourcing Services

Established in 1997, Biotec is a privately owned leading Pharmaceutical services company specialising in cold chain packaging, storage and logistics services.

Based in the UK, Biotec is an audited and approved supplier to a wide range of virtual and blue chip international pharmaceutical and healthcare companies. Phase I-IV clinical trials through to commercial supplies

Biotec offer the following services for Phase I-IV clinical trials through to commercial supplies, from its purpose built facilities:

• Import of supplies into the European Union
• Qualified Person (QP) certification and GMP consultancy
• Labelling, primary and secondary assembly of clinical supplies, marketed products and unlicensed medicines.
• Storage - Controlled ambient (+15°C-+25°C), +2-+8°C, -20°C, -80°C and -196°C
• Stand alone storage
• Global distribution
• Returns and reconciliation

Biotec works to both US and European Quality Standards and has now built up strong partnerships with clients across the world, in particular from the US, Canada, Japan, Israel and Europe. We operate an ISO 9001:2000 accredited Quality Management System and hold the following licences, that include biological products:

• Manufacturing Licence MIA (IMP)
• Manufacturers Licence
• Manufacturers Specials Licence
• Wholesaler Dealer Licence

Cold chain packaging and storage

Equipped to handle the most complex logistics, Biotec can store and distribute clinical and commercial supplies and samples over a wide range of temperatures including controlled ambient (+15-+25°C), +2-+8°C, -20°C, -80°C and -196°C.

The company has been authorised by the HM Revenue and Customs (HMRC) as an Authorised Economic Operator (AEO) and a Department for Transport (DfT) Accredited Known Consignor. The AEO certificate, an internationally recognised quality mark, demonstrates that Biotec operates an international supply chain which is secure, with customs controls and procedures which are efficient and fully compliant.

Manufacturing, product development, labelling and assembly of supplies and logistics management

Biotec's management team consists of highly qualified and capable health care professionals who have experience in manufacturing, product development, labelling and assembly of supplies and logistics management. Seven QPs are employed as part of the team to release supplies of IMPs that have been manufactured outside the EU for use in European clinical studies.

Partnering with Biotec ensures adding value by:

• Improving the timescales for route to market
• Ensuring and innovative and flexible approach
• Facilitating a quick and smooth import into the European Union
• Developing effective relationships and communication channels with client Project Managers, interpreting protocols and converting to finished supplies
• Providing up front consultancy to ensure optimal cost effective patient kit design
• Ensuring that supplies reach the patient on time and within temperature specification

Biotec's growth and success has been recognised by winning the following awards: the Queen's Award for Enterprise in the International Trade category 2009, MediWales Innovation Award for Export 2008.

The Biotec team are available to comment on various pharmaceutical topics including: Cell based therapies, clinical supplies, cold chain technologies, unlicensed medicines, investigator led studies, biosimilars and named patient supplies.

Whether you require a tailor made service to facilitate the transition of your Investigational Medicinal Product (IMP) from development to clinical trial site, a storage solution for your supplies or packing, storage and distribution of commercial supplies, the Biotec team can assist you. Visit our web site at www.biotec-uk.com to find out more.

Biotec House,
Central Park,
Western Avenue,
Bridgend Industrial Estate,
Bridgend,
S.Wales, UK

Tel: +44 (0) 1656 750555
Fax: +44 (0) 1656 757569
enquiries@biotec-uk.com
www.biotec-uk.com