Are Your Data Compliant? New ERA Guideline for Human Medicinal Products in Force Since September 2024
The revised Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00 Rev. 1 – Corr.) came into force in September 2024. For pharmaceutical companies, it introduces additional requirements for Environmental Risk Assessments (ERA). We can support you in meeting these expectations – efficiently, scientifically robust, and fully aligned with the latest regulatory standards.
Our Services for Pharmaceutical Companies
- Systematic literature review in accordance with the current ERA guideline
- Gap analysis: identification of missing studies and data gaps
- Evaluation and conduct of Phase I/II ERAs
- Support in responding to authority queries
Why choose Dr. Brill Regulatory Services?
With more than 20 years of experience in environmental risk assessment, Heike Schimmelpfennig brings extensive expertise from industry, regulatory authorities, and international regulatory frameworks – including over 10 years at ECHA and collaborations with EMA. You will benefit from a unique combination of regulatory know how, scientific expertise, and hands on dossier experience.
Want to Ensure Full ERA Compliance? We support you from initial screening to developing complete assessment documents – compliant, efficient, and strategically sound.
Contact us for a non binding consultation - here: Contact.
Dr. Brill Regulatory Services – Your Partner for Regulatory Excellence in the Pharmaceutical Sector