PDE & HBEL Reports
At QbD Group we have a  specialized area in Toxicological support  composed of a multidisciplinary team of toxicologists and chemical experts accredited by AETOX, EUROTOX and ERT.
Our highly specialized multidisciplinary team prepare PDE/ADE (Permitted Daily Exposure) reports for any API according to the EMA directive (EMA/CHMP/CVMP/SWP/169430/2012) for the pharmaceutical and veterinary industry.
Supported by Azierta part of the QbD Group
Why QbD PDE reports?
- More than 2500 compounds evaluated.
- More than 190 customers worldwide that have trusted us.
- Presence in more than 50 countries.
- Prepared and reviewed by highly qualified toxicologists.
- Include a robust assessment based in scientific information and expert criteria of the evaluator.
- Provide comprehensive discussion for the derivation of the PDE value.
- Evidence precise and reliable value as a result.
- More than 2500 compounds evaluated.
- More than 190 customers worldwide that have trusted us.
- Presence in more than 50 countries.
- Prepared and reviewed by highly qualified toxicologists.
- Include a robust assessment based in scientific information and expert criteria of the evaluator.
- Provide comprehensive discussion for the derivation of the PDE value.
- Evidence precise and reliable value as a result.
Why QbD Group?
QbD supports companies worldwide in the life sciences throughout the entire product lifecycle, from idea to patient.
With more than 10 years providing Toxicology Services, QbD is your partner for advice and support on controlling quality risks.
Our Toxicology Team is member of AETOX organization and the experts are certificated by EUROTOX.
10+ years of experience
Full life cycle support
Global presence
Best Managed Company
Contact us
Need help with your Toxicology? Don’t hesitate to get in touch.
