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 EU principles and guidelines on Good Manufacture Practices (GMP). All clinical trial medication is subsequently certified and released by a Qualified Person (QP).

Comparator Sourcing

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

  • EU GMP certification
  • QP release certification for clinical trial use
  • Imports from Non-EU/third-countries with QP release for EU clinical trial use

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.

Project Management

  • Meticulous project planning with over 200 project control points across the span of a clinical supply project covering project timelines, costings, IMPD data, CTA applications, technical agreements, medication label designs, manufacturing batch records and documentation requirements
  • Extensive trial design assistance including IMP production feasibility and budgeting assistance
  • Optimisation of the trial IMP design by calculating the medication needed and selecting the most sensible IMP option – considering not only variables of the clinical trial (such as patient population factors) but also manufacture and stability dependent factors
  • Unique access to a pan-European network of pharmaceutical contract manufacturers ensuring the best option for your requirements
  • Support the set up of Technical Agreements for the trial
  • Comprehensive co-ordination of all contract manufacturing
  • Ensuring GCP, GMP and GDP requirements around the IMP are met such as labelling requirements and the retrieval of key documentation to support the IMP (Certificates of Analysis, QP release statements and EU GMP statement of compliance)

We do all this so that you can carry out a study with minimal obstacles.