Optimize your Environmental Risk Assessment (ERA) during the MAA procedure

Ensure compliance. Promote sustainability. Minimize regulatory hurdles.

Ensure compliance. Promote sustainability. Minimize regulatory hurdles.
May 6, 2025

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]

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