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QUALITY ASSURANCE

Quality Assurance

We offer a range of Quality services including QP/RP and batch release

Quality Assurance Strategy for all your quality compliance needs

  • Quality Management System (QMS) set up (CAPA/complaints/change control)
  • Audits – internal and third party supplier
  • Clinical Development, Tech Transfers and Commercialisation to scale
  • Inspections – preparation, during inspection and response
  • Investigations into product quality defects
  • Risk Assessments

Authoring of:

  • Quality Overall Summary
  • SOPs
  • Site Master File
  • Site licence applications
  • Technical Agreements

Authoring of:

  • Quality Overall Summary
  • SOPs
  • Site Master File
  • Site licence applications
  • Technical Agreements