Currently, the request for a new marketing authorization for a medicine for human use requires a mandatory Environmental Risk Assessment report.
At Azierta, we develop ERA reports for the assessment and analysis of API effects on the environment.
- Evaluation procedures based on the latest EU guide: EMEA/CHMP/SWP/4447/00.
- Phase I: Determination of the exposure to the substance.
- Phase II: Obtention and evaluation about the fate and effects of the substance in the environment.
- Risk Assessment for each API using the most updated IQVIA data base.
- Specialized environmental toxicologists with wide experience in new drug registrations.
- More than 50 reports carried out in Europe during the last year.
Experts in ERA Reports
We provide specialized toxicological support through a multidisciplinary team of expert toxicologists accredited by AETOX, EUROTOX and ERT.