IMPs management and Comparators sourcing

IMPs Manufacturing

  • Blinding of IMP – e.g., over-encapsulation of a solid oral formulation
  • Batch release and certification by QP (QP release services)
  • Capsules Manufacturing (e.g. Placebo Capsules
  • IMPs Packaging
  • Primary Packaging of solid oral formulations
  • Packaging of all formulations and high potency drugs in cooperation with qualified partners
  • Secondary packaging of all formulations and packaging designs at our production sites
  • Provision of user-friendly packaging materials, controlled to fit quality specifications

IMPs Labeling

  • Label design to enhance compliance of trial subjects. The client’s corporate identity can be integrated into the label
  • Labeling with the mono-/bi-/multi-lingual label (multi-language booklet label, wrap-around label, with or without documentation part/tear-off label)
  • Re-labeling in case of changes, (e.g., protocol amendments, new ‘use-by date’)
  • Compliance with 2001/20/EC, GMP and national drug laws (e.g., AMG), protocol specifications
  • Tear-off label to document subject compliance & drug accountability

IMPs Services

  • Preparation of Emergency Envelops
  • Preparation of IMP section relevant to the IMP preparation
  • Preparation of international Master Label Forms
  • Selection of qualified packaging materials
  • Tailored packaging and labeling designs to meet study needs
  • Importation of IMP from extra-EU countries in agreement with EU requirements

IMPs Packaging

  • Primary Packaging of solid oral formulations
  • Packaging of all formulations and high potency drugs in cooperation with qualified partners
  • Secondary packaging of all formulations and packaging designs at our production sites
  • Provision of user-friendly packaging materials, controlled to fit quality specifications

Comparators Sourcing

Working during the early phases of planning with a partner that can offer reliable information on drug availability, can have a tremendous impact on the speed and efficiency of the process at the study launch phase.

Once the study is running, effective supply chain management is fundamental to ensure uninterrupted supplies to patients. The clinical supply forecasting, the interaction with the key stakeholders in the study to plan for resupplies, and the coordination of sub sequential deliveries are all critical to the success of the trial.

Euromed can support Drug Supply Organizations teams throughout the entire phases of their trials. Thanks to the coordinated work of our team of experts, this can be achieved on a protocol level, a product level, and even on a program level, enabling the entire department to leverage economies of scale and reducing the risk of interruption of supplies.

Our company holds full-line Wholesale licenses in all countries of operations. We can access prescription drugs, over the counter (OTC) medicines, medical and surgical devices, Ancillaries, and Control Substances (in certain regions).
We offer Import/Export and Custom Clearance services
We are in direct contracts with all major pharmaceutical manufacturers
We ensure safe access to products including whenever possible their Certificate of Analyses (CoAs), Certificate of Conformity (CoCs) & TSE/BSE statements