Contract Manufacturing

Torbay Pharmaceuticals specialises in the production of terminally sterilised injectable medicines and a range of oral liquids for both the UK and International markets, we currently supply products in over 17 countries. Our GMP-compliant manufacturing facility is fully licensed by the MHRA.

We provide an integrated range of services starting with development and technical transfer services to support our customers to ensure that their medicines are manufactured, tested, labelled, packaged, stored, QP certified and distributed within the shortest and most effective time frame, to meet tender and supply commitments in local markets.

Regulatory Affairs & Quality

Adherence to regulatory compliance guidelines and GMP is central to all of our actions at Torbay Pharmaceuticals. Our in-house Regulatory Affairs team support Torbay’s own licensed products in addition to, where required, providing a range of services to support CDMO/CMO customers.

Regulatory affairs services:

  • Dossier preparation or review and filling
  • Development of regulatory strategy for the whole product life cycle
  • Facilitate meetings with regulatory agencies

Product Development

Our customers start to work with Torbay Pharmaceuticals at various stages of their drug development projects. Torbay Pharmaceuticals is capable of supporting with drug development services, acting as a CDMO or as your tech transfer partner where development work has already been undertaken. Whichever approach is required we will allocate a dedicated project manager to manage and support the program of work from initial assessment through to transition into commercial production.

Our processes have been designed to be tailored to the needs of your program of work, with our project manager acting as your access point to the wider organisation.

Product development services:

  • Formulation services
  • Analytical development services
  • Technical transfer services
  • Validation of methods
  • Stability testing
  • Program and project management

Sterile Fill Finish

Our manufacturing site provides our customers with the opportunity to focus on the development of niche and low volume generics. With batch sizes ranging from 30 to 600 litres and annual volumes from low thousands up to two to four million units per annum. Today, we reliably support our customers with the sterile and non-sterile filling of drugs into ampoules, vials, bottles and syringes. Enabling our global customer base to meet project milestones, providing rapid access to manufacturing slots and quick release of medicines to ensure tight timelines are successfully met.

Our experienced project management team offers a single point of contact throughout each project, which ensures we communicate with you clearly and as frequently as you need.

Fill finish capabilities:

  • Filling into 2mL-100mL glass vials
  • Filling into 10mL, 50mL, 100mL plastic vials
  • Filling into 1mL – 10mL ampoules
  • Filling into syringes
  • Large volume parenteral 250 – 1000mL
  • Bulk volume from 30 to 600 litres
  • Non sterile manufacturing area
  • Six Grade C filling rooms
  • Automated vial and ampoule filling lines

Labelling, Packaging & Logistics

With our in-house artwork design and label printing services supported, where appropriate, by external partners, Torbay Pharmaceuticals offer an efficient labelling and packaging service tailored to our customers specific needs, which allows us to manage the supply chain logistics of your project and ensure it is delivered to your chosen location.

Labelling & Packaging capabilities:

  • In-house artwork and design
  • In-house label printing
  • Full colour external label and box design and printing
  • Label application with step by step Quality Assurance oversight
  • QA review and certification of GMP records
  • QP review and certification of GMP records

Drug Product Testing

In house chemistry and microbiology laboratories support by coordinating in-process and finished product testing with the completion of batch documentation, we can deliver your drug product within minimal time from the date of manufacture.

Analytical testing capabilities

  • Analytical method development & validation
  • Analytical method transfer
  • Quality control release testing
  • Stability testing
  • Filter compatibility testing
  • Container closure testing
  • Microbiological finished product testing, including sterility, endotoxin and particulates
  • Analytical release testing including HPLC
  • ICH storage and stability testing including  additional capabilities for photostability  and in-use stability testing
  • Life cycle product management services –  Annual commitment stability and Periodic  Quality Reviews
  • We work with approved partners to provide  specific testing

Qualified Person Release & Certification

Our QP’s release fully licensed and unlicensed products under a commercial manufacturer/importer’s (MIA) licence, unlicensed batches under our MS licence and clinical batches under our IMP licence. Manufacturing to GMP regulations, we support QP release to market or direct to you for onward distribution.

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Our portfolio

Our specialist portfolio includes licenced and unlicensed terminally sterilised injectables, high-quality electrolyte ingredient solutions for TPN compounding, and a range of supporting products and services.

Download our latest Product List

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