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PDE-OEL Reports - Toxicology - QbD Group

PDE-OEL Reports

At QbD Group, we offer specialized Toxicological Support Services backed by a multidisciplinary team of accredited experts. Our toxicologists and chemical specialists hold certifications from leading organizations such as AETOX, EUROTOX, and ERT, ensuring the highest level of expertise and quality in every assessment.

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PDE/ADE reports tailored to industry standards

Our highly qualified team prepares PDE/ADE (Permitted Daily Exposure/Acceptable Daily Exposure) reports for any Active Pharmaceutical Ingredient (API) in compliance with the EMA directive (EMA/CHMP/CVMP/SWP/169430/2012). These reports are essential for the pharmaceutical and veterinary industries to ensure product safety and regulatory compliance.

 

Let QbD Group guide you toward precise and reliable PDE values with scientifically robust assessments.

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Why choose QbD Group for your PDE reports?

When it comes to PDE/ADE reports, you need a partner who combines scientific expertise, proven experience, and a commitment to quality. At QbD Group, we deliver all that and more. Here’s what sets us apart:

Extensive experience

Over 2,500 compounds evaluated.

Trusted globally

More than 190 satisfied customers worldwide.

International reach

Expertise delivered across 50+ countries.

Highly qualified team

Prepared and reviewed by certified toxicologists with years of experience.

Robust assessments

Scientifically grounded evaluations combined with expert judgment.

Comprehensive analysis

Detailed discussion supporting the derivation of PDE values.

Reliable results

Evidence-based, precise, and dependable PDE values tailored to your needs.

Why QbD Group?

  • End-to-end toxicology support
    From early development to post-approval changes, we provide integrated risk assessments seamlessly aligned with QA, CMC, and regulatory strategies.
  • Trusted expertise at scale
    With decades of combined experience across diverse projects and markets, our toxicology team provides reliable insights that add efficiency, consistency, and confidence to every assessment.
  • Proactive compliance monitoring
    Through strict oversight of reports, we help clients stay in full control of toxicology obligations, proactively alerting them to potential non-conformities before they become risks.
  • Certified Toxicology Experts 
    Our reports are prepared and reviewed by EUROTOX-certified (ERT) toxicologists, ensuring the highest standards of scientific quality, regulatory reliability, and patient safety across every assessment.


    EUTOTOX
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End-to-end toxicology support

10+ years of experience

Compliance monitoring

Certified toxicology experts

 

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Ready to get started?

Contact us today to request your PDE/ADE report and discover how QbD Group can deliver tailored toxicological solutions for your business.

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