Clinical Trial Material, Packaging & Logistics
With more than 30 years’ experience in Packaging and Logistics of Clinical Trial Material, Eurofins CDMO (Contract Development and Manufacturing Organization) network of companies 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 network of companies 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
Eurofins CDMO & Eurofins Optimed, your clinical trials one-stop shop.
Eurofins Optimed (full service clinical CRO) will help with:
- Clinical Trial Protocol
- Regulatory affairs
- Medical Writing
- Global trial and site management (subject recruitment, monitoring and vigilance)
- Biometry (data management, biostatistics, study report)
- GLP Biology services
Eurofins CDMO network of companies will provide support with:
- Formulation, development and manufacturing of your clinical materials
- Logistics on clinical supply
- CMC RA support
| 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 |
