Ensuring Patient Safety Through Proactive Monitoring And Compliance
We deliver flexible solutions for both established and emerging organisations
Contact UsOur Services
Adverse Event Case Management
Collection, triage, assessment, and reporting of adverse events and product complaints within regulatory timelines.
Periodic Safety Reports (PSURs / PBRERs)
Preparation and submission aligned with current regulatory requirements
Signal Detection and Risk Evaluation
Identification, assessment, and management of emerging safety trends using data-driven tools.
Pharmacovigilance System Master File (PSMF) Development
Creation and maintenance of PSMFs to ensure GVP compliance
Safety Data Exchange Agreements
Drafting, reviewing, and maintaining agreements between marketing partners
Auditing and Compliance Support
Internal audits and gap assessments to prepare for regulatory inspections.