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Qualified Person Services

Product facilitation into the EU.

Qualified Person Release Certification (QP Release) is available as part of Mawdsleys’ Regulatory Services, which complements the company’s wider offering to the pharmaceutical industry and healthcare sector. Clients without an EU presence will benefit from Mawdsleys' extensive experience of accepting pharmaceuticals and biopharmaceuticals into the EU, conducting QP Batch Release and navigating the EU regulations.

By working with Mawdsleys pharmaceutical and biopharmaceutical companies will benefit from an experienced Regulatory Affairs team consisting of EU Qualified Persons (QP’s), EU Responsible Persons (RP’s), Pharmacists, Technicians and Quality Assurance (QA) professionals.

Support for Marketing Authorisations - QP  Batch Release
Mawdsleys can QP Batch Release your products in order for them to be launched into a new territory, supporting marketing authorisation applications.

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

Mawdsleys can help ensure our clients comply, as we have the facility to import or arrange manufacture to EU GMP standards and QP Batch Release clinical trial products in all pharmaceutical forms:

Helping ensure patients have access to the drugs they need, when they need them.

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