With a team of 70 people, Eurofins Amatsigroup is able to handle all types of studies, either for Medical Device or Drug Product, from local phase I to global phase III, for both IMPs and IVPs (Investigational Medicinal Products and Investigational Veterinary Products), applying Just-in-Time/On-Demand labeling and distribution, when appropriate.
All the Clinical Trial Supply activities are managed by a dedicated site in Europe with 30 years of experience and supervised by our on-site corporate Qualified Person. The site currently has total 2,500 m3 of GMP storage at RT, 220 m3/ at 4°C, 20 m3 at -20°C, 5 suites for secondary packaging at RT and 2 suites at 4°C. The facility is fully compliant with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) and was successfully inspected, last in 2015 by the French medicines agencies (ANSM for human medicinal products and the ANSES for veterinary products).
Our qualified carriers and international partners help us supporting our client’s worldwide clinical trials. We have distributed over 50 different countries with a great experience in Western and Eastern Europe as well as in the US. Shipments are managed at all temperature conditions (ambient or controlled, dedicated or not). We also carry the authorization for controlled drug storage & management.
Choose Eurofins Amatsigroup to help you to cover your needs regarding clinical trial supplies:
- Perform the clinical labeling: label design & printing (single panel labels, booklet up to 40 different languages, tear-off labels, flag labels)
- Ensure the good primary packaging: blisters of sterile forms (vials, syringes) and non-sterile forms (capsules, tablets…)
- Design the right secondary packaging: wallets, blister-cards, patient kits for open or double-blind studies
- Manage the QP services: Import, Documentation review, Audits of manufacturing sites, QP agreement, GMP certification, final batch release
- Arrange the Global Clinical Logistics: GMP Storage, Clinical distribution, management of the depots, Returns & Destruction
- Support you regarding all additional services such as management of randomization, management of ancillaries, sourcing of comparators, extension of expiry date…