We provide complete as well as customized trainings on:

  • Standard Operating Procedures (SOPs)
  • Good Clinical Practice (for CROs, Investigators and Coordinators, CRAs and clinical trial managers)
  • Computer System Validation
  • GCP auditing skills
  • Regulatory Inspection Preparedness

    Mock Inspection:

  • Mock GCP Regulatory Inspections
  • Investigative Site Training and Preparedness
  • In process Inspection Support and Facilitation
  • Response creation
  • We have prepared and hosted inspection by various regulatory agencies including DCGI – India, UK MHRA, US FDA, EMEA, Taiwanese FDA, Vietnamese MoH, South Korean FDA, ANVISA – Brazil, WHO, MCC – South Africa and Israel – MoH. These include inspection conducted at BA/BE centers, investigators sites, CROs and sponsor location.


    SOP Development and Management:

  • Process Assessment and Mapping (Flow Chart)
  • Gap Analysis
  • SOPs Development and Administration


Other services include: