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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
www.biotec-uk.com