Vision“By 2012, Biotec will be the market leader in cold chain pharmaceuticalservices, headquartered in the UK with a global presence. We will achieve thisthrough a highly skilled, motivated team using best practice and technologicaladvances.”MissionWe ensure that patients’ and clients’ needs are at the forefront of our businesswhether the medicines are for clinical trials or everyday use.
Background Core ServicesFounded 1997 QP & GMP ConsultancyPrivately owned Clinical SupplyPurpose built facility Unlicensed medicinesQueen’s Award for Enterprise 2009 Marketed ProductCold chain specialists LogisticsFully licensed & inspected by MHRA Stand-alone storage
QP & GMP Consultancy• 6 QPs with wide experience • Assistance with:of all core areas EU regulatory requirements• Manufacturing process Label text compliancereview and development Blinding issues• Facility development • Batch certification• IMPD review• QP audits and familiarisation visitsfor IMP and Marketed Productimportation
Protocol interpretation for kit design and supply strategyClinical Supply: Returns and destruction IVR and IWR controlled studies Global distribution Product specification file Expiry date (PSF) set up extension Randomisation schedules and Patient Pack decode options assembly Primary packing Sourcing of comparators and ancillary products Label and leaflet design, translation and printing using Prisym software
Unlicensed medicines• Management of unlicensed medicines • Compassionate Use:(treatment of patients under Continuation of treatment following the responsibility of the physician) participation in a clinical trial• Named Patient • Biotec can assist with:UK “Specials” legislation, commonly Import authorisationknown as “Named Patient” Labelling and assemblyFrance – ATU QA releaseUS – expanded access Global distribution
Marketed Pharmaceuticals• Biotec can assist with: • Biotec specialises in small batchesArtwork generation for niche marketsMulti language label and leaflet design, • Low temperaturetranslation and printing and difficult-to-handle productsLabel and assemblyQP certificationManagement of invoicing on behalfof licence holder
Biotec can provide the following Logisticsservices (Import and Export services)• Fully qualified shipping systems • A range of temperature monitors to suitfor transport of product at: the specified temperatures15 to 25ºC • GMP storage and re-packaging2 to 8ºC for trans-shipments-15 to -25ºC • Product – specific qualification of shippers-60 to -80ºC & transport systems to meet individual needs-140ºC • A range of specialist courier options• Preparation of shipping documentation • Depots for storage and distribution Customs invoices where appropriate Shipping declarations
Biotec offers:• Temperature controlled storage at • Cold rooms and freezers have Controlled ambient (+15 to +25ºC) back-up condensers Refrigerated (+2 to +8ºC) • Customised non-standard storage Frozen (-15 to -25ºC) solutions on request Ultra-low temp (-80ºC) Vapour (-140ºC) or Liquid Nitrogen (-196ºC) • Available capacity• All areas fully validated, temperature mapped, monitored and linked to emergency back-up