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CEHTRA - Consultancy for Environmental & Human Toxicology and Risk AssessmentCEHTRA's Environmental Risk Assessment for Pharmaceuticals
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Pharmaceuticals / Environment

CEHTRA's Environmental Risk Assessment for Pharmaceuticals Benefit from CEHTRA’s rich experience to successfully manage and complete your dossier according to regulatory requirements for Pharmaceutical Risk Assessment.

Generating relevant data for environmental risk assessing pharmaceutical products is a challenging task

Directive 2001/83/EC, as amended, requests the consideration of potential risks to the environment arising from the use, storage and disposal of medicinal products, as well as potential precautionary and safety measures to be taken, and the preparation of an Environmental Risk Assessment (ERA) Report. As environmental and ecotoxicological data are not always available, particularly for new molecules, they need to be generated from experimental studies performed by accredited laboratories. Monitoring studies for active ingredients, interpreting their results and performing complete ERA in compliance with regulatory requirements necessitates a high level of expertise in ecotoxicology, risk assessment as well as a profound knowledge of all the relevant regulatory texts.

CEHTRA can provide you with all the expert support you need

  • Obtaining the data required for your ERA dossier
    • Step-wise data analysis to determine the necessity and availability of the data required by the regulation
    • Bibliographical searches to fill the data gaps
    • Teasing out the environmental properties of the substance
    • Proposing a testing strategy
    • Monitoring the required studies
  • Preparing the full Environmental Risk Assessment from Phase I to Phase II, Tier B if necessary using experienced and competent experts
    • Phase I completion:
      • PBT (Persistency, Bioaccumulation and Toxicity) assessment of the active ingredient
      • PEC surface water calculations using the most recent epidemiological data
    • If necessary, Phase II assessment:
      • Tier A: environmental fate and effects testing. Determination of the environmental compartments potentially at risk.
      • If necessary, Tier B: extended environmental fate and effects testing: refinement of the aquatic environmental risk assessment and terrestrial environmental risk assessment.
  • Preparing a defence strategy and supporting your scientific debate with the Authorities

CEHTRA has in-depth experience in authorities environmental risk assessment

For over 12 years, our ecotoxicologists and environmental scientists have demonstrated their expertise in the area of plant protection products, biocides and other chemical legislations, all of which require the same OECD studies to be performed as for the ERA of pharmaceutical products. We have monitored thousands of Guideline studies over the last decade and make sure you get a high quality study, fit for purpose and based on sound science. Completed by our deep understanding of regulatory requirements this combination will be a strong ally helping you to prepare environmental risk assessments for your medicinal products.

As a recent example, CEHTRA successfully managed a testing strategy on a substance which had a suspected bioaccumulation potential included in a dermatological medication. In coordination with Regulatory Authorities, this testing strategy avoided PBT classification of the substance at reasonable cost.
 
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®Cehtra • November 2017