Clinical Supply Service

Corden Pharma’s clinical trial units, located at Plankstadt and Caponago, operate as independent and separate areas, but in close collaboration with the formulation development and commercial manufacturing taking advantage of the entire range of the facilities of the Corden group and a professional experienced team.

Corden Pharma’s service includes manufacturing, randomisation / blinding, labelling, packaging, QP-release, storage and worldwide distribution of clinical trial medication including cytostatics (secondary packaging) and cold chain management.

Clinical Manufacturing

  • Solid oral dosage forms: Production of tablets, capsules, powders and granules
  • Non-sterile liquids and suspensions
  • Over-encapsulation / blinding
  • Placebo preparation

Comparators

Comparator procurement out of one batch, including CoA, CoC and BSE-free statement

Label Printing and Labelling

  • Label layout and approval
  • 100% inspection of all clinical labels
  • Documented 100% reconciliation
  • Generation of randomisation lists
  • Code-breaking envelopes
  • Multi-lingual booklet labels and wrap around labels

Packaging / Pre-production service

  • Interpretation of study protocols and conversion into optimized packaging design
  • In-house packaging design department

Primary packaging

  • Solid oral dosage forms: Tablets, capsules, powders, granules:
    • Packaging into various blister types (PVC/PVDC, Aclar, Alu/Alu)
    • Filling of bottles with and without induction sealing
    • Stick packs

Secondary packaging

  • Tablets and capsules, including cytostatics, hormones and hormone blockers (high potency), syringes, powders, granules, topicals, inhalants: Wallets, visit boxes, patient kits, centre boxes, shipment boxes, graphic packaging design

Analytical/ QA-Service

  • In-house lab
  • Analytical method development, method transfer and method validation
  • Stability tests according to ICH
  • Release testing
  • Issuance of CoA
  • QP release

Distribution

  • Worldwide distribution
  • IVRS/IWRS
  • Shipment tracking with modern communication systems
  • Cold chain distribution management, including refrigerated and frozen shipment
  • Data logger system
  • Return drug reconciliation and management
  • Certified destruction