Key Services

  • QMS support from design to effective operation
  • Regulatory inspection readiness activities
  • Post Regulatory inspection review and follow up
  • Pharmaceutical GMP auditing


Key highlights

  • 30 years in the Pharmaceutical Industry
  • Underlying philosophies are "keep it simple" and "cost effective quality"
  • Worked in multi- national, Japanese, contract manufacturing and virtual organisations
  • Built up good relationships with outsourcing organisations.
  • Conducted hundreds of GMP audits of all major dosage forms
  • Conducted numerous "mock" GMP inspections and assisted with Regulatory Inspection preparation
  • Experienced in the manufacture and packing of solid dose, semi solid and sterile products, (including both terminally sterilised and aseptically prepared products).
  • Experienced in the manufacture, blinding, packing and labelling of Investigational Medicinal Products for multi-national trials.
  • Experienced Qualified Person and Qualified Person Assessor
  • Associate of the Link Management Group

Other Services offered

  • Qualified Person mentoring and support
  • Senior Management workshops