Quality, Regulatory, Clinical

What We Do

QA and Regulatory Compliance

All aspects of Quality Systems Management to support clinical development programmes, from Phase I – IV:

Quality Management Systems:

  • Set up & maintenance.
  • Periodic QMS meetings
  • Internal system audits and SOP gap analysis

SOP writing:

  • Preparation of procedures and associated forms and templates
  • Review and update of procedures

Vendor and systems audits (GCP/GCLP):

  • Clinical CRO
  • Data Management & Statistical analysis services
  • Pharmacovigilance services (clinical trial safety reporting)
  • Clinical laboratory bioanalysis services (GCLP)
  • Phase I unit audits 
  • Technical translation services
  • IMP packaging, labelling and distribution services
  • Remote vendor audits by tailored questionnaire
  • Computer System Validation status assessment and audit

Clinical trial audit plans, including:

  • TMF audits
  • GCP Investigator site audits (global)
  • Phase I study audits
  • Essential document QC 

Preparation for agency inspections:

  • Inspection-readiness training
  • Mock inspection including mock interviews
  • Investigator site preparation
  • Inspection report response support