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We offer the following services:

OUR SERVICES

- Training​

  • Internal GCP, GCLP, GLP & PV/Vigilance (GVP) Auditing Training

  • Investigator Meeting GCP Training

  • Inspection Readiness Training

  • Internal Auditors’ Training

  • Basic & advanced Training in Clinical Development

  • Pre-Inspection Clinical Investigational Sites audits & training

  • GCP, GLP, GVP, GDP training (Internal staff & Investigator Meetings) basics to advanced 

- Compliance

  • GxP Gap Analyses & support with remedial actions
  • Risk Evaluation & Management 

- Auditing

  • GCP, GVP, GLP and GCLP process, system & vendor Audits

- GxP Standard Procedures

  • Development & review of written procedures
  • Development of Quality Manual 

- Quality Management Systems

  • Advise, Build & Support​

- Regulatory Authority Inspections

  • Training on inspection preparation
  • Conducting Mock Inspections

  • Support with hosting inspections

  • Support with responses to inspection findings & CAPA