Clinical trial support
The Wasdell Group provides manufacturing, primary and secondary packaging and global storage and distribution services for all study phases.
We specialise in the clinical manufacture of non-sterile oral solutions and provide a range of clinical trial manufacturing services.
Our clinical trial manufacturing capabilities
- Investigational medicinal product (IMP) manufacture in the recommended dosage form and placebo manufacture
- Sourcing of comparators, non-investigational medicinal products or auxiliary medicinal supplies
- Release testing the batches or performing stability studies for IMPs with adherence to BP/EP standards
- On site Analytical laboratory for ID testing
- Dry heat sterilisation and Grade C material sampling.
We offer a full range of clinical packaging and distribution services to meet the needs of clinical trial sponsors throughout Europe/
Our clinical packaging and distribution capabilities include:
- Just in Time (JIT) labelling service, which is designed to create efficiency by reducing inventory costs, avoiding repackaging work and preventing waste
- Ability to accommodate all trial requirements – open, double-blinded or JIT approaches
- Our clinical trial packaging professionals can deblister, debottle, or over-encapsulate tablets/capsules along with packing pharmaceuticals in bottles, blisters, sachets, tubes and wallets
- Multi-language label design including all European languages, Russian and Chinese
- Post study returns, accountability and destruction
- Temperature controlled worldwide shipment, storage and distribution capacity for clinical trial pharmaceuticals
- Auditing of the complete supply chain to meet Annex 13 and 16 requirements and support subsequent commercialisation.
We are also able to provide Qualified Person Release Certification to meet the QP certification requirements for clinical trials, as well as QP EU release for imported IMPs. In this way we are able to help our customers ensure they comply with the Clinical Trial Directive 2001/20/EC.
Selecting the best partner
The Wasdell Group is experienced in meeting high quality standards and tight deadlines as well as offering comprehensive documentation. Our expert knowledge and broad range of capabilities mean we can help our customers take their clinical products to market as quickly and effectively as possible.