PDE-OEL Reports
Specialized toxicological support backed by accredited experts
QbD Group prepares PDE/ADE reports for any Active Pharmaceutical Ingredient in compliance with EMA directives. Our ERT-certified toxicologists deliver scientifically robust assessments for the pharmaceutical and veterinary industries.
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.
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.
Extensive experience
Over 3,500 compounds evaluated.
Trusted globally
More than 600 satisfied customers worldwide.
International reach
Expertise delivered across 50+ countries.
Highly qualified team
Prepared and reviewed by ERT-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.
Our process
We follow a structured approach to deliver PDE/ADE reports that meet the highest standards of scientific quality and regulatory compliance.
1. Initial consultation
Understand your specific needs and regulatory concerns.
2. Data collection
Gather necessary documentation on the compound and its toxicological profile.
3. Toxicological assessment
Comprehensive literature review and expert evaluation to derive PDE values.
4. Report delivery
Provide a detailed PDE/ADE report with full scientific justification.
5. Follow-up support
Ongoing assistance for regulatory queries or updates.
Why QbD Group
Your trusted partner
Our reports are prepared and reviewed by EUROTOX-certified (ERT) toxicologists, ensuring the highest standards of scientific quality, regulatory reliability, and patient safety.
End-to-end toxicology support
from early development to post-approval changes.
Trusted expertise at scale
decades of combined experience across diverse projects and markets.
Proactive compliance monitoring
strict oversight to stay ahead of evolving regulations.
Certified Toxicology Experts
EUROTOX-certified (ERT) toxicologists on every project.
FAQ
Frequently Asked Questions
Let's talk Toxicology
From risk assessments to regulatory compliance, our toxicology experts are ready to support your pharmaceutical needs.