Clinical Trial Materials Manufacturing Services
GMP clinical trial material manufacturing services to meet your 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 a flexible and consistent contract services 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 analytical testing, method development and validation, 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):
WORKSHOP: How to Build an Inhaler (RDD 2023)
PRESENTATION:E&L Strategies (3rd Annual Extractables & Leachables Conference)
TALK: Medical Device Extractables & Leachables Studies
TALK: ID and sensitivity issues during E&L studies
ARTICLE: Glycosylation Analytical Approaches for Antibody Therapeutics
APP NOTE: Rapid Determination of Low/Trace Level Benzene in Pharmaceutical Excipients and Finished Products
ARTICLE: Importance of Aligning a Pharma Audit Scope with the Correct Standard
TALK: mRNA Analytics: Capping Efficiency, Sequencing, Poly-A Tail, dsRNA
Our inhalation services downloads
White paper download: Formulation of Biologics for Inhaled and Nasal Delivery
Webinar recordings: Stability Programs for Orally Inhaled or Nasal Drug Products
Formulation Strategies for Orally Inhaled and Nasal Drug Products
Brochure download: Inhalation Product Development Services
GMP Pharmaceutical Analysis and Formulation Expertise
Saxon Way, Melbourn
Herts, SG8 6DN
Laboratory Expansion for Specialist OINDP Development for Biologics