Navigating complex safety requirements with confidence.

With deep clinical expertise and global regulatory insight, we help you navigate complex safety requirements - ensuring your products remain safe, compliant, and trusted throughout their lifecycle.

Signal detection & management
  • Continuous monitoring of safety data for emerging risks
  • Quantitative and qualitative signal detection
  • Signal validation, prioritisation, and documentation
  • Regulatory communication and follow-up strategy
Global literature search & review
  • Systematic screening of global and local literature
  • Identification of reportable adverse events and safety signals
  • Compliance with international standards
  • Documentation and submission of literature ICSRs
Aggregate reporting
  • Authoring of periodic safety reports
  • Integration of global safety data and benefit-risk analysis
  • Regulatory-compliant formatting and submission
  • Cross-functional input from clinical, regulatory, and medical teams
Safety report writing
  • Development of clear, concise narratives and aggregate reports
  • Accurate documentation tailored to regulatory and partner expectations
Risk Management Plans (RMPs)
  • Development and maintenance of compliant RMPs
  • Identification of safety concerns and risk minimisation strategies
  • Integration with post-marketing activities
Risk Evaluation & Mitigation Strategies (REMS)
  • Design and implementation of REMS programs
  • Development of communication plans and tools
  • Monitoring and assessment of REMS effectiveness
  • Stakeholder coordination
DSMB/SRC charter & support
  • Drafting charters for DSMBs and safety review committees
  • Coordination of safety data review meetings
  • Preparation of safety summaries and recommendations
  • Regulatory-aligned documentation