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CDMO >> Services >> Clinical Trial Material, Packaging & Logistics

Clinical Trial Material, Packaging & Logistics

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With more than 30 years’ experience in Packaging and Logistics of Clinical Trial Material, Eurofins CDMO (Contract Development and Manufacturing Organization) supports Global studies from clinical phase I through to clinical phase III for both Investigational Medicinal Products (IMPs), as well as Investigational Veterinary Products (IVPs).

Our on-site QP’s (Qualified Person) oversee all Clinical Trial Supply activities, including primary and secondary packaging, labelling, storage, and worldwide distribution. We have provided distribution to over 50 different countries including the U.S, India, Australia, and many in Western and Eastern Europe, the Middle east and the Far East.

Our significant cold chain capacities enable us to store, manage and distribute a wide range of clinical trial material

Choose Eurofins CDMO to help you:

✔ Meet your regulatory needs for clinical trial supplies for Drug Products and Medical Devices.

✔ Support you with specialised services such as management of randomisation, double-blind study, management of ancillaries, sourcing of comparators, and extension of expiry date.

✔ Placebo manufacturing (sterile and non-sterile)

✔ Provide just-in-time or on-demand labelling and distribution.

✔ Manage you GMP storage and shipment requirements at controlled temperature conditions.

✔ Manage and store your controlled drug substances.

✔ Manage the QP services.

Our Facilities

With multiple suites for primary and secondary packaging, as well as significant GMP storage, our facilities in France are fully compliant with Good Manufacturing Practices (cGMP) and Good Distribution Practices (GDP):

  • GMP storage space:
    • + 15 / + 25°C: 560 m3 / 19775ft3
    • + 2/ + 8°C: 146 m3/ 5156 ft3
    • - 20°C: 2.6 m3 / 92 ft3
    • - 80°C: 0.5 m3 /  17 ft3
  • Primary Packaging GMP building
    • Seven  suites Class C (Iso 7)
    • Three suites Class D (Iso 8)
    • Temperature & humidity monitored
  • Secondary Packaging GMP building  
    • Ten suites at Room Temperature
    • Three suites at + 2/ + 8°C
    • Cold chain Management
Clinical Trial Materials, Packaging & Services
Primary Packaging
Blisters of Sterile Forms (Vials, Syringes) Blisters of Non-Sterile Forms (Capsules, Tablets)  Others (Bottles, Satchets)
Secondary Packaging & Labeling
Wallets Blister-Cards Label Design & Printing
Single Panel Labels Booklet up to 40 Different Languages Tear-Off Labels
Flag Labels Patient Kits for Open or Double-Blind Studies  
QP Services
Import Documentation Review Audits of Manufacturing Sites
QP Agreement GMP Certification Final Batch Release
Global Clinical Logistics
GMP Storage Clinical Distribution Management of the Depots, Returns & Destruction
 

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