Wasdell clinical services

The Wasdell Group provides clinical manufacturing, primary and secondary packaging and global storage and distribution services for all study phases. Our team takes a consultative approach and tailors our service to your specific project requirements. Our facilities can accommodate controlled drugs, along with variations in lot size and volume, various packaging formats and complex multi-arm studies requiring hand-pack and assembly.

We offer automated packaging solutions for multiple dosage formats, as well as bespoke engineering solutions through our technical division. All our pharmaceutical products are manufactured and packaged under GMP and GCP conditions, as well as being stored and distributed under GDP conditions.

Clinical trial manufacturing capabilities

We specialise in the clinical manufacture of non-sterile oral solutions and provide a range of clinical trial manufacturing services, including:

  • QP (Qualified Person) Release Certification
  • QP EU Release for imported IMPs
  • Clinical Trial Directive 2001/20/EC compliance
  • On site microbiology laboratory
  • On site Analytical laboratory for ID testing
  • Dry heat sterilisation and Grade C material sampling
  • IMP (Investigation Medicinal Product) manufacturing
  • Placebo manufacturing
  • Sourcing of comparators, non-investigational medicinal products or auxiliary medicinal supplies
  • Adherence to EU, US, BP (British Pharmacopoeia) and JP (Japanese pharmacopoeia) standards.

Clinical packaging and distribution capabilities

We provide a full range of clinical packaging and distribution services to meet the needs of clinical trial sponsors throughout Europe, including:

  • 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
  • Deblistering and debottling
  • Multi-language label design including all European languages, Russian and Chinese
  • Post study returns, accountability and destruction
  • Worldwide shipment, storage and distribution capacity for investigational medicinal products
  • Primary and secondary product labelling for clinical trial packaging
  • Auditing of the complete supply chain to meet Annex 13 and 16 requirements and support subsequent commercialisation.

Selecting the correct partner

Selecting the correct contract partner for clinical trial manufacturing and packaging services is critical to getting your product to market as quickly and efficiently as possible. Any mistakes during early development phases or meeting packaging requirements can cause costly delays.

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.