Good Laboratory Practice

Initial business opportunities involved set-up of GLP systems and routine GLP service provision to small companies.

To date, more than twelve GLP systems have been created or improved, with QA involvement in over twenty regulatory GLP inspections by UK MHRA.

Business expansion resulted in increased work conducting pre-approval and routine for-cause client inspections of GLP facilities and GLP facilities conducting clinical analysis.

PMS staff work to provide a GLP QA service to a variety of GLP clients on a routine basis, and have extensive experience in multi-site studies.

  • Extensive experience for set-up and QA service provision for GLP systems in-vivo, and in bioanalysis, histology and microbiology areas.

  • Client pre-approval and for-cause inspections of GLP CROs in Europe and USA. Protocol and Amendment reviews for multinational studies.

  • QA set-up and servicing of multi-disciplinary quality systems incorporating GLP, GCPv, ISO17025 and other systems.

  • QA review and project management for supply of Test Items on a worldwide basis.

  • Some experience in GLP for medical devices.

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