Medecines logo

Staphyt Regulatory can advise and support you in all the regulatory procedures required for assessing the environmental impact of your medicinal products as per Directives 2001/83/EC (medicinal products for human use) or 2001/82/EC (veterinary medicinal products).

Thanks to its experience in environmental and ecotoxicological risk assessments for plant protection products, biocides and chemicals in the broad sense, our team is able to assist you in conducting environmental risk assessments for your human and veterinary medicinal products, and thus meet the regulatory requirements relating to environmental protection.

You need to

  • Understand and follow European regulations in this field,
  • Determine the ecotoxicological and environmental studies required for your marketing authorisation application,
  • Set up laboratory studies (GLP),
  • Prepare the ecotoxicological part of your marketing authorisation dossier (module 1.6) for your human medicines,
  • Assess the environmental risk of your veterinary medicinal/veterinary products,
  • Determine whether your medicine is exempted of the environmental risk assessment,
  • Assess the risks of cross-contamination when manufacturing your medicines,
  • Defend your dossiers before the French or European authorities.

Our expertise

  • Help you to understand the applicable regulations,
  • Define the optimum strategy (costs and timing) for conducting the environmental risk assessments on your medicines,
  • Assess existing studies and identify the missing or critical data,
  • Develop a test strategy and monitor the OECD/ISO studies under GLP,
  • Audit the laboratories conducting your studies,
  • Carry out all or part of the environmental risk assessment on your medicines, in accordance with the requirements of the European Directives,
  • Draw up a rationale to justify an exclusion case,
  • Calculate the acceptable exposure levels for the ecosystems (PNEC calculation),
  • Conduct customised environmental risk assessments,
  • Assess the risks of cross-contamination when manufacturing medicines, and calculate the PDEs (Permitted Daily Exposure),
  • Support you in your exchanges with the French or European authorities,
  • Conduct tailored technical or regulatory training,
  • Translate all types of document.

Other business areas