Extractables & Leachables Reports
Expert toxicological assessments for packaging and device safety
QbD Group provides toxicological assessments and risk evaluations for extractable and leachable impurities, designed to fit your specific needs and ensure compliance with FDA, EMA, and ICH standards.
What are extractables & leachables reports?
The risk and toxicological assessment of extractable and leachable impurities is a crucial process in the pharmaceutical industry to ensure the safety and quality of products.
These impurities, which can migrate from packaging materials or medical devices into the final product, represent a potential risk to patients. Regulators such as the FDA and EMA require detailed reports to support the safety of drugs and medical devices.
How can we help?
Our team of toxicologists and analytical chemists work together to perform in-depth analyses, risk assessments, and toxicological evaluations.
Risk assessment
Analysis of possible compounds released from drug contact materials, assessing their impact on safety and determining safe limits.
Toxicological evaluation
For all impurities outside established limits — compilation of harmful effects, toxicity determination, and health risk assessment using QSAR methods.
Customized reports
Reports tailored to meet specific regulatory requirements for each pharmaceutical product and client.
Regulatory alignment
Compliance with FDA, EMA, USP 1663, USP 1664, and ICH Q3E guidelines.
Our process
We provide customized reports that meet the specific regulatory requirements for each pharmaceutical product and client.
1. Initial consultation
Understand your specific materials and regulatory context.
2. Material analysis
Identify potential extractable and leachable compounds from packaging and device materials.
3. Risk & toxicological assessment
Evaluate safety impact and determine whether impurities are within safe limits.
4. Report preparation
Deliver comprehensive, submission-ready reports aligned with regulatory standards.
Why QbD Group
Your trusted partner
We combine in-depth technical knowledge with a detailed understanding of international regulations, ensuring customized and rigorous reports.
Specialized, multidisciplinary team of toxicologists and analytical chemists.
Customized reports according to the specific regulatory requirements and needs of each client.
Approach combining in-depth technical knowledge with understanding of international regulations.
AETOX membership and EUROTOX certification
the highest professional standards.
FAQ
Frequently Asked Questions
Let's talk Toxicology
From risk assessments to regulatory compliance, our toxicology experts are ready to support your pharmaceutical needs.