Clinical Trial Material, Packaging & Logistics
With more than 30 years of Clinical Trial Material experience in Packaging & Logistics, Eurofins CDMO (Contract Development & Manufacturing Organization) supports studies from local phase I to global phase III for both Investigational Medicinal Products (IMPs), as well as Investigational Veterinary Products (IVPs).
Our on-site Qualified Person (QP) oversees all Clinical Trial Supply activities, including primary and secondary packaging, labeling, storage, and worldwide distribution. We have distributed to over 50 different countries with vast experience in Western and Eastern Europe, as well as in the U.S., India, Australia, Lebanon, and Singapore with qualified partners.
We are able to handle a large range of products with our cold chain capacities through all clinical trial material steps.
Choose Eurofins CDMO to help you:
✔ Meet all regulatory needs regarding clinical trial supplies for Drug Products & Medical Devices.
✔ Support you with specialized services such as management of randomization, management of ancillaries, sourcing of comparators, and extension of expiry date.
✔ Provide just-in-time/on-demand labeling and distribution.
✔ Manage GMP storage and shipments at all temperature conditions.
✔ Manage and store your controlled drug substances.
✔ Manage the QP services.
With multiple suites for primary and secondary packaging, as well as ample GMP storage, our facilities are fully compliant with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP):
- 3,545 m3 / 125,190 ft3 of GMP storage space:
- 3,000 m3 / 105,944 ft3 at RT
- 500 m3/ 17,657 ft3 at 4°C
- 45 m3 / 1,589 ft3 at -20°C
- Five suites for secondary packaging at RT
- Two suites for secondary packaging at 4°C
|Clinical Trial Materials, Packaging & Services|
|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|
|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|