Why Euromed Pharma
Whether you need support for clinical trial materials such as investigational medicinal products, comparator medicinal products, and placebos, or planning an early access program, a named patient program
Why Euromed Pharma
IMP Manufacturing
The ability to store more than Prescription and OTC, Nutraceutical, and raw materials, API.
Our team manages the storage and distribution of products in ambient and cold chain conditions including import/export services. Thanks to our Supply Chain consulting services we can offer guidance on several critical variables in the planning of your operations. We recommend the best transportation methods based on products, point of departure and destinations. We assess and evaluate the assumption on regulatory requirements mitigating the risk of delay in shipments during delicate transitions such as customs clearances. We identify the optimal packaging solution so that the product is protected from any temperature excursion along the whole way.
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.
Multilingual labelling options: adapting to global requirements
Innovative IMP labelling techniques
IMPs Labelling:
- Label design to enhance compliance of trial subjects. The client’s corporate identity can be integrated into the label.
- Labelling with the mono-/bi-/multi-lingual label (multi-language booklet label, wrap-around label, with or without documentation part/tear-off label)
- Re-labelling 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 labelling 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.
Together throughout your drug’s lifecycle
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