Ensuring Environmental Safety with Comprehensive ERA Services
On September 1, 2024, a new guideline for ERA of pharmaceuticals has been published by the European Medicines Agency (EMA).
What is ERA?
Environmental Risk Assessment (ERA) is a critical process that evaluates the potential impact of medicinal products on the environment. As a regulatory requirement, ERA is essential to protect ecosystems and ensure that pharmaceutical substances do not adversely affect our natural surroundings. ERA often is a critical component of the Marketing Authorisation Application (MAA). For many companies, the need for ERA becomes apparent during the MAA process, where regulatory bodies require a thorough evaluation of a medicinal product's environmental impact.
At CSB Compliance, we specialize in providing thorough and compliant ERA services that align with regulatory standards, including those set by the European Medicines Agency (EMA). Our comprehensive ERA services are designed to ensure that your application meets all regulatory requirements, paving the way for successful market entry.
We offer a full suite of Environmental Risk Assessment (ERA) services designed to meet the specific needs of your medicinal products. Whether you’re in the early stages of product development or preparing for regulatory submission, our expert team is here to guide you through every step of the ERA process.
Why is ERA Important?
ERA is not just a regulatory checkbox; it's a commitment to environmental stewardship. In an era where environmental sustainability is paramount, assessing the ecological impact of medicinal products is more important than ever. Failing to comply with ERA requirements can lead to significant delays in product approval, potential fines, and even restrictions on market access.
Our ERA services are designed to help you navigate these challenges with confidence. We offer a comprehensive approach that ensures your products are both environmentally safe and regulatory-compliant, minimizing risks and enhancing your brand’s reputation.
Regulatory Compliance and Reporting
Navigating the complex regulatory landscape can be challenging, but with CSB compliance, you’re in capable hands. We prepare all necessary ERA documentation for your regulatory submissions, ensuring full compliance with EMA guidelines and other relevant regulations. Our experts are available to provide ongoing consultation and support, helping you stay ahead of evolving regulatory demands. If needed, we can also advise any needed testing scenarios.
Tailored Solutions for Every Product
Every medicinal product is unique, and so are its environmental risk assessment needs. We understand this, which is why we customize our ERA services to align with your specific objectives and regulatory obligations. From initial risk screenings to comprehensive assessments, our solutions are designed to deliver the precise insights you need for successful product development and approval.
Our Services at a Glance
- Literature/Database Search
- Data Gap Analysis
- Planning of test strategies and study monitoring
Phase I Assessment - Phase IIA/B Assessment
- PBT Assessment
- Modelling (i.a. SimpleTreat)
- Tailored testing strategies for specific modes of actions (Antibacterials and EDs)
Contact us today to find out more about our
Environmental Risk Assessment (ERA) services.