Clinical Trial Material Manufacturing Services

Our GMP clinical trial materials manufacturing can help you meet supply needs for Phase I, II and III pharmaceutical clinical trials. With GMP-compliant, inspection-ready facilities, our clinical trial supply services team provides agile, responsive project delivery with integrated analytical and CMC support. 

From Concept to Clinic: End-to-End Clinical Trial Manufacturing Support 

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 worldwide.  
 
Our integrated GMP clinical trial materials manufacturing approach combines early-stage process development and scale-up, pilot batch manufacturing and GMP batch manufacturing to ensure robust, reproducible production suitable for clinical supply. It also includes formulation development, device selection, and compatibility assessments to ensure safety, performance, and regulatory compliance. 
  
Supported by raw material characterisation and sourcing we also provide expertise in analytical testing, method development and validation, particle engineering, OINDP characterisation and performance testing, cleaning development and validation, GMP release testing and Qualified Person (QP) release, delivering a fully integrated, one-source solution for clinical trial materials supporting Phase I–III studies. 
 
With our MIA (IMP) License, we provide IMP clinical trial supply solutions 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 bulk label, prior to shipping.  

Why partner with Intertek as your clinical trial material supply partner? 

• 30+ years of expertise in clinical trial manufacturing.
• 75,000+ sq ft GMP facility dedicated to clinical manufacturing, with controlled environments (temperature/humidity), laboratories and stability storage.
• MIA (IMP) licensed clinical material supply for Phase I, II and III investigational medicinal products. In house QP.
• Integrated concept-to-clinic capabilities spanning formulation, particle engineering, analytical development, GMP manufacture and batch release.
• Regulatory-proven quality systems, including FDA pre-approval inspections and MHRA GMP oversight.
• Specialist support for innovative inhaled and nasal therapies, including dry powder, liquid formulations and large molecules.
• Flexible Scope - beyond OINDP we also provide CTM manufacturing for oral capsules and liquids and dermal products. 

Clinical Batch Manufacturing Enabling Next Generation Inhaled Therapies 

With our expanded GMP facility in Melbourn, near Cambridge, UK, we offer flexible capacity for multiple clinical trial material manufacturing campaigns to be run concurrently for OINDP products. With specialist knowledge for the manufacture of small-scale orally inhaled and nasal drug products and experience across pMDIs, DPIs, Unit/Bi-Dose Liquid Nasal Sprays​, Nebulised Solutions, Suspensions or Emulsions​, Multidose Liquid Nasal Sprays​ and Unit-Dose Nasal Powder​, nebulisers, nasal sprays, soft mist inhalers, we can meet your needs for next generation OINDPs.  

Quality-driven clinical trial supplies manufacturing and development backed by regulatory expertise  

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 our CTM manufacturing and global clinical supply support complies with GMP. We are audit ready with a proven track record in supporting regulatory submissions. 

Example equipment clinical trial manufacturing services 

Our clinical trial manufacturing is supported by controlled temperature and humidity environments and a suite of precision equipment including:  

• ProCepT 4M8-TriX spray dryer
• MG2 FlexaLab capsule filler
• Mettler Quantos powder/liquid dosator
• Tubular low-shear mixers
• Silverson homogenizer/mixers
• CrystecPharma’s proprietary crystal and particle engineering ‘mSAS®’ (modified Supercritical Anti-Solvent) drug formulation technology 

Clinical Trial Manufacturing & Analytical Support 

• GMP-compliant inhalation product testing supporting clinical development across pMDIs, DPIs, nebulisers, and nasal delivery systems.
• End-to-end analytical services including method development & validation, product performance, chemical and physical characterisation including particle flow, powder characteristics and dissolution.
• Robust stability programmes (accelerated & real-time) to support clinical trial materials and shelf-life determination.
• Advanced inhalation testing capabilities including delivered dose uniformity, particle/droplet size, and spray characterisation.
• Specialist biologics expertise using orthogonal analytical methods aligned with ICH Q6B to assess structure, purity, and potency.
• Device–formulation interaction studies including extractables & leachables for combination products.
• Comprehensive product characterisation under real-world and in-use conditions to ensure performance and regulatory compliance. 

Bringing quality and safety to life, we offer Total Quality Assurance and integrated GMP capabilities with advanced manufacturing equipment to support your clinical trial material needs from early development through to Phase I–III supply. Speak with our team today to accelerate your program with a reliable, fully integrated one-source solution.