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Biotec Services International Limited

Pharmaceutical Outsourcing Services

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Biotec Services International Limited

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.

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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.

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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.

Contact

Biotec House
Central Park
Western Avenue
Bridgend Industrial Estate
Bridgend
S.Wales
UK
Tel: +44 (0) 1656 750555
Fax: +44 (0) 1656 757569
Email: enquiries@biotec-uk.com
URL: www.biotec-uk.com

Quick Contact Biotec Services International Limited


Advanced Therapeutics Medicinal Products

Advanced Therapeutic Medicinal Products (ATMPs) are the new exciting frontier in medicine potentially heralding revolutionary treatments of a number of diseases and injuries.

With you, as you shape the futureBiotec's mix of storage and clinical knowledge enables us to provide innovative solutions overcoming potential issues with storage, labelling and delivery at cryogenic temperatures. Biotec has been actively involved over the last decade, extending our QPs' extensive biopharmaceutical experience and specialist knowledge as well as our proven expertise in…

Clinical Supplies

Choosing Biotec as your investigational products service provider will add value to your project. We act as an extension to your team by being involved very early on in your project offering advice and guidance. Our Project Managers will work with you to devise a project plan, developing agreed goals and timelines to maximise project efficiency.

Managing your supplies, from protocol to patientWe oversee the whole of your project:Our QPs will define your clinical supplies strategy guided by Biotec's unique 'Product Supply Route Map'Arrange for the collection of supplies from the site of manufacture for delivery to Biotec ensuring all import documentation is provided to the required authoritiesProviding Qualified Person Consultancy…

Commercial Services

Global companies, of various sizes, seeking to enter the commercial market call upon Biotec's expertise to assist with the commercial launch of their product following completion of successful Phase I to IV clinical trials.

Your trusted route from clinical trial to marketOur expertise with temperature sensitive niche products and orphan drugs means Biotec is well placed to guide them through this process. We can assist with every aspect, from packaging and labelling through to temperature controlled dispatch...anywhere in the world. Not all our clients are medium to large sized....many…

Global Logistics

We never forget that our clients' products save and improve people's lives. Our role in storing, handling and transporting your supplies reflects our absolute commitment to quality and safety. Our track record speaks for itself: thousands of temperature-sensitive shipments delivered every year... safely, securely, and on time, globally.

Our knowledge, delivering your productsThe Biotec logistics team are highly experienced in the Import/Export licensing procedure. They know precisely the requirements involved and have developed a trusted, proven supply chain using specialist, fully validated international couriers with full tracking systems. Everything is thought through - from ensuring that named personnel receive the shipments through to…

GMP Temperature Controlled Storage

Our recently-extended GMP storage areas - arranged across a split site - make us the perfect storage provider. These areas are fully validated, continuously monitored and alarmed, and offer different storage temperatures, from controlled ambient right down to -196°C. The breadth and quality of our service - from one-off samples through to commercial supplies - make us highly flexible and responsive to every client's needs.

Your products, safe in our handsWe are not only qualified to collect, store and deliver clinical trial and pharmaceutical products, we can also provide the collection, storage, return and reconciliation of patient - including blood, urine and tissue. Once again, this makes us the perfect partner in temperature controlled storage. Our GMP pharmaceutical storage services…

QP & GMP Consultancy

Qualified Persons (QPs) play a vital role in bringing products - especially new products - to market with Europe. Global clients look to the diverse range of skills and specialism of our highly experienced team of QPs to ensure their clinical studies, and commercial supply operations not only meet the most rigorous standards but also run smoothly, seamlessly and cost-effectively.

Quality expertise to guide and direct youThe diversity of experience within our ever-expanding team of Qualified Persons means we deal quickly and expertly with specific issues and technical challenges right across the pharmaceutical dosage spectrum, from small molecules to biopharmaceuticals and advanced therapeutic medicinal products. Auditing manufacturing facilities anywhere in the world is part of…
Quick Contact Biotec Services International Limited
Quick Contact Biotec Services International Limited
Quick Contact Biotec Services International Limited


Quick Contact Biotec Services International Limited
Quick Contact Biotec Services International Limited
Quick Contact Biotec Services International Limited


Contact Biotec Services International Limited

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Quick Contact Biotec Services International Limited