ERA for Pharmaceuticals

In ERA for pharmaceuticals, evaluating a pharmaceutical’s potential environmental impact requires expertise in both drug development and environmental testing. Eurofins Regulatory Science Services' environmental risk assessment capabilities for human and veterinary pharmaceuticals provide the environmental data and guidance you need to meet testing and timing requirements.

We help develop drugs and evaluate their environmental impact. As partners with pharmaceutical and animal health companies, Eurofins Regulatory Science Services has a long history of supporting drug development with a broad array of CMC services. We have a deep understanding of global regulatory requirements for environmental submissions and can guide you through the assessment process with accurate timelines.

Eurofins Regulatory Science Services will help you get started at the optimal time to avoid submission delays. With environmental risk assessment studies taking 10 to 12 months—or longer—our program managers and scientific advisors will guide you to successful completion.

Our industry leadership in chemical registration support is based on our acquisition of Wildlife International, ABC Laboratories, PTRL West and PTRL Europe. With more than 120 years of combined laboratory experience in studies involving environmental fate, ecotoxicology, plant and animal metabolism and product chemistry, our scientists design and execute the right experiments to produce quality data.

Our Environmental Risk Assessment capabilities include:

• Evaluation of testing needs
  • Aquatic toxicology
  • Terrestrial toxicology
  • Metabolism
  • Environmental fate
  • Product chemistry
  • Radiolabeling & custom synthesis
  • Method development/method validation
• Document preparation
  • Categorical exclusions
  • FDA-CVM Environmental Assessments
  • FDA-CDER Environmental Assessments
  • EMA Environmental Risk Assessments

Contact erssinfo@eurofins.com for more information!