Manufacturing & Packaging of Clinical Supplies
MODEPHARMA’s network model allows us to offer the full spectrum of manufacturing services for investigational medicinal products (IMPs). Our services are applicable to open-label, single-blind, double-blind, and double-dummy studies ranging from smaller phase I through to larger phase IV studies.
All manufacturing/packaging of clinical supplies is undertaken to high quality standards in certified GMP manufacturing units licensed for the manufacture of IMPs as per current UK and EU Good Manufacture Practices (cGMP). All clinical trial medication is subsequently certified and released by a Qualified Person (QP).
Manufacture of trial medication and placebos-to-match
- Solids tablets, film-coated tablets, effervescent tablets, bi-layer tablets, capsules, powder and granules
- Complex dosage forms such as slow-release and bi-layer tablets
- Semi-solids including gels, creams, ointments, lotions, suppositories
- Sterile and non-sterile liquids including solutions, emulsions, and suspensions
- Nasal-solutions
- Over-encapsulation of tablets and capsules
- Encapsulation of API via Xcelodose System Precision Powder Micro-dosing System
- Manufacture of sensitive material including hormones, controlled-drugs, Beta-lactums, cytotoxics and peptides
- Metered-dose inhalers (MDI)
- Patches
Innovative and cost-effective packaging solutions
- Customised patient kit design and assembly (PVC or carton with inserts, wallets)
- Blister PVC/ALU, PVDC/ALU, PP/ALU, ALU/ALU
- Multi-product blisters
- Bottles, pots and containers (glass and plastic)
- Pump sprays
- Injectables including ampoules and vials
- Prefilled syringes
- Sachets and tubes
Randomisation and labelling
- Randomisation list generation
- Labelling assistance to achieve Annex 13 compliance
- Blinding of medication
- Code break envelope printing
Analytics and Stability Testing
- Quality control on APIs, drug products
- Cleaning validation
- Microbiological testing
- Stability study setup according to ICH guidelines
- ICH stability storage and testing of samples
- Stability study reports
- Batch release testing
- Shelf-life determination
QP Release and Imports
- UK and EU GMP certification
- QP release certification for clinical trial use
- Imports from third-countries with QP release for UK and EU clinical trial use
- QP oversight for importation from approved countries
Monitored Storage
- Dedicated storage rooms
- Freeze facilities (down to -80degC)
- Segregation and stock-keeping
- Dedicated facilities for controlled drugs
- Monthly stock reports
Distribution and Shipments (UK and Worldwide)
- Comprehensive distribution management
- Management of both small and larger deliveries
- GDP-compliant distribution of products worldwide in ambient conditions or unbroken cold-chain
End-of-Study Services
- Drug reconciliation
- End-of-study drug returns and destruction with certification
Call +44 207 0432 442