Environmental Risk Assessment (ERA) for medicinal products intended for human use is required under Directive 2001/83/EC. CEA offers the expertise and guidance needed to ensure compliance with this directive. ERA involves evaluating the fate and hazard profiles of medicinal products to identify potential risks to the environment.
CEA will help you initiate the process at the optimal time to avoid delays in submission. By combining our testing and regulatory expertise, we can create the most efficient and suitable dataset for your product. With most ERA studies taking at least 12 months to complete, our experts will support you throughout the process to ensure successful completion of the process.
Leveraging extensive experience across various legal frameworks, we tailor solutions specific to your product. By staying up to date with emerging guidelines and regulatory changes in the EU, we know exactly what is required and how to meet regulatory expectations.
Because of our multidisciplinary expertise and building on our track record of higher-tier environmental risk assessment, we have built a full ERA support service to comply with Directive 2001/83/EC . Consequently, our services include:
• Regulatory project management
• Development of effective strategies to meet compliance
• Expert review and evaluation of data
• Data- gap analysis and literature searches
• Placement and monitoring of experimental studies
• Endocrine disruptor assessments
• Support from across the CEA team, including toxicology, ecotoxicology and environmental fate and behaviour
• Preparation of reports and other documents
• Communication and advocacy meetings with Member State competent authorities