Marc Renaud
Quality Director — Medical Device manufacturer
"Filab delivered a full ISO 10993-18 chemical characterization with a rock-solid AET justification. Our notified body accepted the dossier on first review."
5/5
5/5 sur Avis Vérifiés
Extractables & Leachables (E&L) Testing
- 45+ years of Life Sciences expertise
- Fully certified laboratory operations (ISO 17025 accredited)
- 100% compliant with FDA, European MDR & ICH guidelines
- Custom AET calculation
COFRAC
Accréditation N° 1-1793
FDA
Aligned submissions
ASTM / ISO
Standards
ISO 10993-18
Standard
Inside the lab · Dijon, France
5,200 m² accredited facility·100+ certified analysts·30 years expertise
Accreditations & standards
Accredited E&L testing capabilities
Our Extractables & Leachables studies are executed under ISO 17025 accreditation and aligned with the most demanding international guidelines for Medical Devices and Pharmaceuticals.
ISO 17025 (COFRAC 1-1793)ISO 10993-12ISO 10993-18ICH Q3EUSP 1663USP 1664USP 661.1USP 661.2USP 665USP 1665BPOG Protocols
E&L services
Two markets, one accredited E&L lab
- Medical Devices (DM): ISO 10993-12 | ISO 10993-18 FDA & MDR compliant
- Pharmaceuticals: ICH Q3E Guideline | USP <1663> & <1664> | USP <661.1>, <661.2>, <665> & <1665> | BPOG Protocols
Need a compliant testing protocol for your product?
🧬
Medical Devices (MD) E&L Services
For implantable MDs (stents, catheters…) or administration devices (syringes, bags…), FILAB ensures full compliance with European MDR and US FDA expectations.
- Sample Preparation: Meticulous conditioning and extraction according to ISO 10993-12 🛡️ (Under ISO 17025 Accreditation).
- Chemical Characterization: Comprehensive testing according to ISO 10993-18 🛡️ (Under ISO 17025 Accreditation).
- AET Evaluation: Expert calculation and robust justification of the Analytical Evaluation Threshold (AET).
🔍 Ensure your Medical Device compliance before submission.
Discuss Your Project with an Expert💊
Pharmaceutical E&L & Packaging Services
FILAB supports pharma manufacturers by providing full testing coverage aligned with the ICH Q3E guideline to secure container-closure systems and manufacturing components.
- Extractables & Leachables Studies: Identification and quantification following USP <1663> (Extractables) and USP <1664> (Leachables).
- BPOG Protocols: E&L testing for single-use manufacturing components according to Bio-Phorum Operations Group guidelines.
- Plastic Packaging Characterization: Evaluation of plastic systems and components according to USP <665> and USP <1665>.
- Material & Drug Interactions: Chemical testing and verification of plastic materials of construction according to USP <661.1> and USP <661.2>.
📦 Protect your drug product from packaging contamination.
Request a Tailored ProtocolContext & Regulatory Challenges
Why E&L Testing is important?
Navigating the evolving regulatory landscape for Medical Devices and Pharmaceuticals is highly complex. Failing to provide robust, accredited Extractables & Leachables data can result in severe market approval delays from authorities like the FDA or European Notified Bodies (MDR).
- 01
Patient Safety First
Ensuring no toxic chemical substances migrate from packaging, production components, or implantable devices into the drug or human body.
- 02
Complex Data Interpretation
Accurate identification of trace elements requires high-end analytical equipment and precise Analytical Evaluation Threshold (AET) justification.
- 03
Strict Audit Readiness
Regulatory bodies demand studies executed under strict quality standards and fully validated protocols (ISO 10993, USP, ICH, BPOG).
⚠️ Don't let regulatory gaps delay your market launch.
Get Regulatory Guidance from Our Experts
Our E&L Process
From protocol to approval
- 01
Request & scope definition
Submit your project details via our form. Our E&L experts analyze your matrix, targeted regulations (FDA, MDR, ICH) and get back to you within 24h.
- 02
Customized protocol & quote
We design a compliant testing strategy tailored to your product, including required standards, AET calculation methods and transparent pricing.
- 03
Controlled sample preparation
Send your medical devices or packaging. We manage strict traceability and sample extraction/conditioning according to ISO 10993-12 or USP guidelines.
- 04
Advanced analytical testing
Analyses performed in our ISO 17025 accredited lab using high-end chromatography and spectrometry to detect, identify and quantify trace extractables and leachables.
- 05
Regulatory-compliant report
You receive a comprehensive digital data package ready for your submission — raw data, precise substance identification and expert toxicological interpretation.
Why Filab for your E&L studies
Life Sciences expertise you can trust
From early-stage development to final submission, we deliver the accredited analytical data required to secure patient safety and accelerate regulatory approval.
ISO 17025 Accredited & Audit-Ready
Fully certified data (COFRAC Scope N° 1-1793) eliminates the risk of regulatory rejection by EU notified bodies or the FDA.
Dual Market Expertise
Dedicated E&L workflows for both Medical Devices (MDR/FDA) and Pharmaceuticals (ICH/USP/BPOG).
Direct Expert Access
Speak directly with the analytical chemists and regulatory engineers managing your project — no middlemen.
State-of-the-Art Analytical Park
Over 5,200 m² of laboratory space equipped with advanced chromatography and spectrometry for ultra-trace detection.
5/5 avis vérifiés
Trusted by Life Sciences leaders
From medical device manufacturers to global pharmaceutical and biopharma companies, our clients rely on Filab for critical E&L decisions.
Sophie Bauer
Regulatory Affairs — Pharmaceutical company
"Their E&L team designed a USP <1663>/<1664> study perfectly aligned with ICH Q3E. Clear protocol, fast turnaround, and a toxicology-ready report for FDA."
5/5
James Liu
Process Engineer — Biopharma manufacturing
"We rely on Filab for BPOG extractables on all our single-use bioprocess components. Reliable data, audit-ready, and direct contact with the analytical chemists."
5/5
Need an E&L study for EU or FDA?
One study, dual compliance — EU MDR & FDA integration
Our experts design the study best suited to your device, timeline and target market, delivering the robust analytical data required to support your submission to notified bodies or the FDA.
ISO 17025 accepted by EU notified bodies & FDA
COFRAC Scope N° 1-1793 — accredited results recognized for regulatory submissions worldwide.
One study, dual compliance
Seamless EU MDR and FDA integration in a single, optimized E&L protocol.
Robust analytical reporting
Submission-ready data packages with raw data, identification and toxicological interpretation.
Direct access to specialist chemists
Speak directly with the engineers running your study. Response within two business days.