---
title: "PDE-OEL Reports — Toxicology Services | QbD Group"
description: "QbD Group prepares PDE/ADE reports for any Active Pharmaceutical Ingredient in compliance with EMA directives. Our ERT-certified toxicologists deliver scie"
url: https://qbdgroup.com/en/services/toxicology/pde-oel-reports
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"PDE-OEL Reports — Toxicology Services | QbD Group\", https://qbdgroup.com/en/services/toxicology/pde-oel-reports"
---

# 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

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## Let's talk Toxicology

From risk assessments to regulatory compliance, our toxicology experts are ready to support your pharmaceutical needs.

Contact us

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Source: https://qbdgroup.com/en/services/toxicology/pde-oel-reports — © QbD Group. Quote freely with attribution and a link back.