The updated Environmental Risk Assessment (ERA) Guidelines, effective from September 2024, introduce stricter regulatory requirements for medicinal products. These changes demand a thorough environmental evaluation for all new Marketing Authorization Applications (MAAs), with a strong emphasis on protecting the ecosystem.
At Asphalion, we’re here to guide you through these evolving regulations. Our team of experts is ready to assist you with:
- Impact Assessment – Evaluate the effect of the new ERA guidelines on your ongoing projects.
- Compliance Review – Ensure your ERA documentation aligns with the latest standards.
- ERA Report Preparation – Prepare detailed, compliant ERA reports for regulatory submissions.
If you’re currently working on an MAA or need to update your ERA dossier, now is the time to ensure compliance with these new guidelines.
Contact us today to discuss how we can support you in meeting these regulatory requirements and keeping your projects on track! [email protected]
