In today’s increasingly complex regulatory landscape, a robust Environmental Risk Assessment (ERA) is not just a requirement—it’s a cornerstone of responsible pharmaceutical development. At Asphalion, we understand the challenges of aligning scientific accuracy with regulatory expectations. That’s why we offer a comprehensive, step-by-step approach to elevate your ERA process and ensure full compliance with current guidelines.
Here’s how we can support you:
- Full collection & analysis of available environmental data:
We gather and interpret all relevant environmental data for your active substance, forming the foundation of a solid ERA. - Screening of Pesistence, Bioaccumulation and Toxicity (PBT):
Our team compiles detailed insights into the substance’s behavior, including its physicochemical properties and pharmacological profile. - In-depth risk & hazard evaluation:
We conduct a thorough assessment to identify potential environmental risks, ensuring a proactive rather than reactive strategy. - Comprehensive ERA report and analysis of main gaps:
We deliver a complete, scientifically sound ERA report supported by existing literature. In cases where the latest guidelines highlight areas not fully covered by current data, we provide a clear gap analysis identifying required ecotoxicity studies that can be addressed post-commercialization. - Study minimization strategies:
Our experts help reduce the number of required studies through smart planning—preserving both your budget and project timelines without sacrificing quality. - Expert Signature
Every ERA report is finalized with an official Expert Signature, ensuring both regulatory compliance and scientific credibility.
Is your ERA is fully optimised to support a smoother MAA procedure?
Let’s connect and explore how we can tailor our services to your specific needs.
Contact us at: [email protected]
