To ensure your pharmaceutical is accepted by regulatory authorities, you need to assess its potential environmental effects via discharge in sewage. This can take more than two years. A dedicated environmental risk assessment (ERA) team can provide global regulatory and analytical support to produce environmental reports that inform public health decisions and are critical for accelerating your product to market.
Define your needs and we will build a program to meet them
We believe success for any program is built on a proactive working partnership—you bring your extensive insight on your product and we bring our regulatory scientific expertise and insight from working with regulators globally. Guided by your information, our consultants will conduct extensive literature searches and a comprehensive review as the base from which to recommend studies you need and identify waivers for others.
Regulators around the world use similar tests to evaluate environmental risk, but they follow different assessment approaches. We will leverage our operational capability and regulatory expertise to match your program to all your target markets: the EMA’s phased approach, the FDA’s tiered approach and other regulators’ approaches.
A customized testing program to meet your needs
After customizing a test strategy for your needs, we provide comprehensive data for your pharmaceutical across the full range of ERA testing, from our 100 operational and analytical staff specializing in:
- Physicochemical testing
- Aquatic ecotoxicology
- Environmental fate, bioaccumulation and metabolism studies
- Terrestrial ecotoxicology
At each step in the program, we evaluate test data, provide scientific justifications for decisions on subsequent actions and hold discussions with regulators where relevant. We assess whether precautions are required to limit the potential environmental impact of your pharmaceutical, which may result in specific labeling, and we provide a complete ERA report and, if needed, post-submission reports.
Trusted study coordination and communication
Working with us, you have access to experts at every step. Your ERA program manager will be your dedicated contact, able to liaise with expert consultants who bring scientific and regulatory insights. We work proactively and collaboratively, providing comprehensive, cross-functional input to deliver on your programs in a timely, cost-effective way.