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.
I. 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.
II. Risk Assessment for each API using the most updated IQVIA data base.
III. Specialized environmental toxicologists with wide experience in new drug registrations.
IV. More than 50 reports carried out in Europe during the last year.
We provide specialized toxicological support through a multidisciplinary team of expert toxicologists accredited by AETOX, EUROTOX and ERT.