Quality & Regulatory Track Record
The human link between your molecule and patient's recovery.
 | FDA & EMA APPROVED |
Operate with confidence through an audit-ready quality system, a clear regulatory track record, and robust QC/QA practices at every stage. An internal CQ and robust Quality practices at every stage.
Partner with quality experts
QUALITY & REGULATORY
Audit-Ready. Proven Compliance.
FDA-approved since 2020, ANSM-inspected, built on 25+ years of regulated manufacturing — so your program moves forward with confidence.
 Regulatory Track Record
FDA-approved facility since 2020 (Two commercial products), ANSM-compliant, with a consistent regulatory history across multiple inspections and filings.
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Inspection Readiness
Successfully passed regulatory inspections by FDA and ANSM — most recently in 2025 — demonstrating sustained compliance and operational excellence.
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Robust QA Governance
Strong quality systems covering deviations, CAPA, and change control — supported by electronic batch records and ERP traceability (SAP®) — ensuring full control, auditability, and continuous improvement.
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QUALITY SYSTEM
Proven Quality Framework
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QC: in-process controls (IPC), release testing, and stability studies — coordinated to ensure product quality, consistency, and regulatory compliance at every stage. |
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QA: robust quality management system including validation, qualification, data integrity — ensuring full control and audit readiness. |
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Regulatory: CMC support, dossier documentation, and regulatory response management |
REAL-WORLD RESULTS
Trusted by Quality & Regulatory Leaders
 “LFB quality system stood out for its rigor, transparency, and audit readiness — giving us full confidence throughout development and regulatory interactions.”
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| Fabentech – Head of QA/QC |
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Your patients deserve a quality system that never compromises. So do you.
Let’s talk about your next submission.
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| Contact us |