Finished Drug Product Support
Once your product is manufactured, Eurofins BioPharma Product Testing also offers associated testing, quality, packaging, and logistics support for your clinical trial materials.
Packaging and Labeling Materials
Working with qualified vendors, Eurofins BioPharma Product Testing can help design and produce kits, labels (including booklet, multi-language labels), instructional inserts, and shipping containers to meet the needs of your clinical trials. Our expertise and flexible approach to designing and developing labeling and packaging materials affords tailored solutions to your clinical trial material needs.
Packaging and Labeling Services
Eurofins BioPharma Product Testing provides small-scale labeling, randomization and kitting services for your clinical trial materials. For randomized trials, clients should provide a randomization list that we will incorporate into packaging batch records to produce the required materials.
We have ample storage capacity in controlled environmental areas maintained at -80 °C, -20 °C, 2 to 8 °C, ambient, and controlled room temperatures. All controlled environmental areas are secure, validated, monitored, and alarmed. We also provide distribution (using qualified shipping providers), receiving, inventory, reconciliation, and destruction support.
Eurofins BioPharma Product Testing offers the capacity and breadth of capabilities to test your finished drug product in a timely manner.
We test materials against specification for identity, potency, impurities, physical properties and safety under strict cGMP compliance, and we customize individual programs to streamline lab documentation and reporting for the most efficient and quality-focused data deliverable possible.
Our network of 25 global facilities are available to support timely quality control and release testing of finished product batches.
Eurofins BioPharma Product Testing provides industry-leading biochemistry, chemistry, molecular and cell biology and microbiology testing services to support your bio/pharmaceutical product. We perform compendia methods or client-specified method, and can also design studies specific to your project needs to support:
- Marketed & Clinical Stability & Release Testing
- Support of Method Development/Validation
- Comparator Product Testing
- Protocol Writing
- Storage & Distribution of Reference Materials
- Retain Program Management
- Capability to Store and Analyze Controlled Substances
- Storage only
As the largest network of GMP Bio/Pharma Product Testing labs worldwide, Eurofins BioPharma Product Testing is an industry leader, providing the most comprehensive offering of chemical and microbiological Quality Control (QC) testing across 25 facilities worldwide.
Our extensive Quality Assurance (QA) groups and Qualified Persons (QP) oversee the completion of all batch documentation, clinical labeling/packaging, storage and distribution complete with QP release.
We can also provide a QP to monitor manufacturing activities and certify the activities before ultimately releasing the product for use.