Choose the Right Team for Your ERA Assessments

Since the assessment of environmental risk for human drugs became a requirement in 1998 (US) and 2006 (Europe), several Q&A documents have been published by both the FDA and EMA. In March 2024, EMA published the revision of the Guideline for ERA of medicinal products for human use. The legal effective date of this revision is 1 September 2024.

With extensive experience in both testing and risk assessments for different legal frameworks, Charles River's Expert Group on Environmental (Risk) Assessment (ERA or EA) for medicinal products for human use is ready to assist you. Our track record dedicated to ERAs for human medicines covers more than 100 projects where consulting was included and even more for testing. Our technical and regulatory expertise enables us to build the most efficient and suitable dataset for your product.

Our team includes study directors with a strong background and many years of experience in physico-chemical properties, analytical methods, environmental fate, and ecotoxicology testing, and regulatory consultants with a high level of scientific expertise and know-how on regulatory aspects. With our vast experience in conducting risk assessments for a variety of legal frameworks, we always find the best solution for your drug. By following emerging new and changing guidelines and guidance, we know what to expect and how to meet regulators' expectations.

If you've committed to conducting an ERA, you might wonder what your next steps should be considering the guideline revisions. How do you future-proof your submission against the upcoming changes?

Do you have a question for our team?