Preparing medicinal product safety documentation in support of product registration is a challenging, multidisciplinary process requiring broad expertise
Safety & Risk Management: RMP and REMS

FMD K&L supports applicants and marketing authorization holders in preparing, collecting, and assessing risks according to regulatory standards, and then develops strategies to mitigate those risks. Our aim is to identify potential problems before they occur and address any issues that may arise before they escalate.

Our risk management services are all aligned with good pharmacovigilance practice requirements. We can assist in preparing detailed pharmacovigilance plans, RMPs, and REMs. Our team offers extensive expertise in assessing and suggesting mitigation strategies for risks related to medicines, consumer products, medical devices, and OTC products.

Our experience includes preparation of:
  • Safety information reviews & revisions
  • All sections of medical assessments
  • Full safety profiles
  • Risk-related position papers from various databases
  • Risk/benefit evaluations
  • Integrated summaries of safety (ISS)
  • Product expectedness lists
Our safety professionals can also assist you with:
  • Providing oversight & tracking of medical monitoring
  • Preparing template-based content
  • Performing thorough literature searches & assessments of epidemiology
  • Identifying important risks & missing information
  • Reviewing & determining adequate routine and additional risk minimization measures
  • Generating submission-ready RMPs
  • Processing assessment checks documenting the effectiveness of risk mitigation strategies