Our Expertise

Deep knowledge across pharmacovigilance platforms and regulatory frameworks

Platform Expertise

Argus Safety

Comprehensive CSV for Argus implementations with FDA, EMA compliance

Veeva Vault Safety

Cloud-based validation for Veeva's pharmacovigilance solutions

LifeSphere Safety

Complete validation services for Aris LifeSphere safety systems

ArisGlobal Safety

End-to-end CSV for ArisGlobal drug safety platforms

Regulatory Frameworks

FDA Requirements

  • 21 CFR Part 11
  • Electronic Records & Signatures
  • Data Integrity

EU Requirements

  • EU Annex 11
  • GAMP 5 Guidelines
  • Data Protection

Quality Standards

  • ALCOA+ Principles
  • GxP Compliance
  • Data Integrity

Global Agencies

  • PMDA
  • MHRA
  • EMA
  • FDA
  • Other Global Regulators