Clinical Trial Materials Manufacturing
GMP Pharmaceutical clinical trial material manufacturing services to meet supply needs for investigational medicinal product (IMP) or investigational new drugs (IND) for clinical trials around the world
Clinical trial materials manufacturing, to meet the supply needs of Phase I and II pharmaceutical clinical trials, requires flexible and consistent service provision partner. Whilst sourcing high quality supplies within trial timelines, you will need clinical trial supply manufacturing that is both fully GMP compliant and responsive.
Our clinical trial supplies manufacturing services are delivered from our state-of-the-art Good Manufacturing Practice (GMP) compliant facilities supporting investigational medicinal product (IMP) or investigational new drugs (IND) for clinical trials around the world.
Integrated with raw material characterisation and sourcing, formulation development, scale up, pilot batch manufacturing and testing, cleaning development and validation, GMP batch manufacturing and GMP release testing with QP release, we offer a one source solution for supplies for use in Phase I and II clinical trials.
With our MIA (IMP) Licence, we provide IMP manufacturing service for non-sterile dosage forms including orally inhaled and nasal drug products (OINDP), powders, capsules, liquids and semi-solids for use in clinical trials. For early stage development, we can package and label prior to shipping.
We have been successfully inspected by FDA as part of pre-approval inspections (PAI), required for New Drug Applications (NDA). Integrated with analysis, formulation development and clinical stability storage testing, we make it possible to screen a wide range of formulations, in a cost and time effective manner, in order to identify those which are most promising, which we would then manufacture. As a result, we can save you time by reducing method and technology transfer effort.
Our facility is biannually inspected by the MHRA, the regulatory body within the UK, which carries out inspections to ensure that manufacturing sites comply with GMP. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards for your products.
Related Good Manufacturing Practice (cGMP):
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