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Environmental Risk Assessment: ERA reports

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

eurotox

We provide specialized toxicological support through a multidisciplinary team of expert toxicologists accredited by AETOX, EUROTOX and ERT.

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 2,000 clients

9 year experience

10 years of experience

Innovation

Leading innovation

Client oriented

100% client oriented

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