FMD K&L offers comprehensive services to assist cosmetics companies in complying with regulatory directive
Safety & Risk Management: Cosmetovigilance

We offer both clinical safety services documenting the safety of unmarketed products and their ingredients, and post-marketing surveillance of adverse reactions.

Prior to July 2013, the safety of cosmetic products was not reviewed or approved by national regulatory authorities. Since then, new legislation has compelled the cosmetics industry to provide data on products and ingredients before they can be marketed. Cosmetics companies must also collect reports of undesirable effects and adverse reactions after their products have reached the market.

Clinical safety services

  • Consultation to optimize clinical safety programs by maximizing claims & minimizing redundant testing
  • Clinical safety testing:
    • Non-acnegenicity
    • Non-comedogenicity
    • Patch tests, including cumulative irritation & sensitization
    • Multiple applications of tests under both controlled & normal-use conditions
  • Compilation & development of cosmetic product safety reports & product information files
  • Document writing, including technical justifications & safety attestations
  • Detailed cosmetovigilance plans
  • Risk management strategies
  • Benefit/risk-related services

Post-marketing surveillance service

The July 2013 regulations require a higher level of post-marketing surveillance and reporting of adverse events (AE), serious adverse events (SAE), and serious undesirable effects (SUE). FMD K&L has established a center of excellence (CoE) to help clients comply with these regulations. The CoE features a highly trained medical professional who will assess and report on AEs, SAEs, and SUEs received by the client.

This service includes:
  • Case intake
  • Case triage
  • Data entry & acquisition
  • Quality control
  • Tracking & reporting of AEs, SAEs, and SUEs
  • Medical review for submission to regulatory authorities worldwide