Qualified Person Services

Qualified Person Release (QP Release) is available as part of Mawdsleys’ Regulatory Services, which complements the company’s wider offering to the pharmaceutical industry and healthcare sector. For clients without an EU presence, we have extensive experience of accepting pharmaceuticals and biopharmaceuticals into the EU, conducting QP Release and navigating the EU regulations.

Mawdsleys have an experienced Regulatory Services team consisting of EU Qualified Persons (QPs), EU Responsible Persons (RPs), Pharmacists, Technicians and Quality Assurance (QA) professionals.

From our wide range of services, we can help with as much or as little as you need:

  • Site Audits, Proposals and Technical Agreements
  • Product facilitation into Europe and QP Release
  • Named Patient Programmes (distribution on named patient basis)
  • Regulatory services for licensing
  • Analytical Testing

Qualified Person (Investigational Medicinal Product) Release - QP(IMP) Release

To comply with the Clinical Trial Directive 2001/20/EC, all companies and sponsors undertaking clinical trials in the EU will need Qualified Person (QP) services to release Investigational Medicinal Products (IMPs) into the EU.

We have the facility to import or arrange manufacture to EU GMP standards and QP Release clinical trial products in all pharmaceutical forms:
  • Investigational Medicinal Products (IMPs)
  • Non investigational Medicinal Products (nIMPs)
  • Advanced Therapeutic Medicinal Products (ATMPs)
  • Biologicals
  • Placebos
  • Comparators

As part of the wider Mawdsleys' offering, we also provide:

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Regulatory Services
Clinical trial services
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(3PL) Third Party