Biotec Services International Ltd

Vision

“By 2012, Biotec will be the market leader in cold chain pharmaceutical services, headquartered in the UK with a global presence. We will achieve this through a highly skilled, motivated team using best practice and technological advances.”

Mission

We ensure that patients’ and clients’ needs are at the forefront of our business whether the medicines are for clinical trials or everyday use.

Background Core Services

Founded 1997 QP & GMP Consultancy

Privately owned Clinical Supply

Purpose built facility Unlicensed medicines

Queen’s Award for Enterprise 2009 Marketed Product

Cold chain specialists Logistics

Fully licensed & inspected by MHRA Stand-alone storage

Biotec’s wide product experience includes:

• BiopharmaceuticalsMonoclonal antibodies

Vaccines

Therapeutic proteins

• Advance Therapy Medicinal products

Stem cells

Gene therapies

Tissue Engineered product

• DevicesFor patient use

For surgical use

• Small moleculesOral

Injectables

Topicals

Inhalation products

• Controlled drugs(schedules 3 and 4)

QP & GMP Consultancy

• 6 QPs with wide experienceof all core areas

• Manufacturing processreview and development

• Facility development

• IMPD review

• QP audits and familiarisation visitsfor IMP and Marketed Product importation

• Assistance with:EU regulatory requirements

Label text compliance

Blinding issues

• Batch certification

Clinical Supply:

Protocol interpretation for kit design and supply

strategyIVR and IWR

controlled studies

Product specification file

(PSF) set up

Randomisation schedules and decode options

Sourcing of comparators

and ancillary products

Label and leaflet design, translation and printing using Prisym software

Primary packing

Patient Pack assembly

Expiry date extension

Global distribution

Returns and destruction

Unlicensed medicines

• Management of unlicensed medicines(treatment of patients under the responsibility of the physician)

• Named PatientUK “Specials” legislation, commonlyknown as “Named Patient”

France – ATU

US – expanded access

• Compassionate Use:Continuation of treatment followingparticipation in a clinical trial

• Biotec can assist with:Import authorisation

Labelling and assembly

QA release

Global distribution

Marketed Pharmaceuticals

• Biotec can assist with:Artwork generation

Multi language label and leaflet design, translation and printing

Label and assembly

QP certification

Management of invoicing on behalfof licence holder

• Biotec specialises in small batchesfor niche markets

• Low temperatureand difficult-to-handle products

Biotec can provide the following Logisticsservices (Import and Export services)

• A range of temperature monitors to suit the specified temperatures

• GMP storage and re-packaging for trans-shipments

• Product – specific qualification of shippers & transport systems to meet individual needs

• A range of specialist courier options

• Depots for storage and distribution where appropriate

• Fully qualified shipping systemsfor transport of product at:15 to 25ºC

2 to 8ºC

-15 to -25ºC

-60 to -80ºC

-140ºC

• Preparation of shipping documentationCustoms invoices

Shipping declarations

Biotec offers:

• Temperature controlled storage at Controlled ambient (+15 to +25ºC)

Refrigerated (+2 to +8ºC)

Frozen (-15 to -25ºC)

Ultra-low temp (-80ºC)

Vapour (-140ºC) or Liquid Nitrogen (-196ºC)

• All areas fully validated, temperature mapped, monitored and linked to emergency back-up

• Cold rooms and freezers have back-up condensers

• Customised non-standard storage solutions on request

• Available capacity

Experience& Excellence:

Tel: +44 1656 750 550

enquiries@biotec-uk.com

www.biotec-uk.com