The Standard of
Trust & Compliance

At BrownBiology Laboratory, quality is not a separate department鈥攊t is the foundational pulse of every chromatogram we generate and every report we issue.

Our Certification Matrix

Operating under the most rigorous international regulatory frameworks to ensure global market access for your products.

GLP

Good Laboratory Practice

Comprehensive compliance for non-clinical safety studies, ensuring the highest standards of data integrity and reliability for IND/NDA submissions.

Referential / FDA 21 CFR Part 58 / OECD
GMP

Good Manufacturing Practice

Certified for the analytical testing and quality control of pharmaceutical products, biologics, and clinical trial materials.

Referential / EU GMP Vol. 4/ FDA 21 CFR Part 211
GCP

Good Clinical Practice

Precision bioanalytical support for clinical trials, ensuring patient safety and the ethical handling of human biological samples.

Referential / ICH E6 (R2)
GDP

Good Distribution Practice

Maintaining the quality and integrity of pharmaceutical products and samples throughout the entire supply and storage chain.

Referential / EU GDP 2013/C 343/01
ISO 9001

Quality Management

Our overarching Management System ensures consistent customer satisfaction and continuous improvement of all internal processes.

Referential / ISO 9001:2015

Data Integrity
Without Compromise

Our independent Quality Assurance department operates outside the production chain, reporting directly to senior management to ensure absolute impartiality in every audit.

The ALCOA+ Principles

We strictly adhere to ALCOA+ standards: Data must be **Attributable, Legible, Contemporaneous, Original, Accurate**, plus Complete, Consistent, Enduring, and Available.

40+
Annual Sponsor Audits
100%
Critical Data Review
Precision Data Verification
Official Accreditation plaques

Global Inspection History

Our laboratory network is routinely inspected by major global health authorities. We maintain an exemplary track record with no critical findings, reflecting our robust internal culture of readiness and compliance.

EMAEuropean Union
Verified & Compliant
Last Inspection: 2023
FDAUnited States
Verified & Compliant
Last Inspection: 2023
National AgencyLocal/EU
Full GMP/GLP Certification
Last Inspection: 2024
ANVISABrazil
Approved Vendor
Last Inspection: 2023

Our Quality Policy

"Quality is not an endpoint, but the foundational principle of every analysis we perform. We are committed to the constant evolution of our systems to protect patient safety through analytical excellence."

FDA 21 CFR COMPLIANTEMA ANNEX 11ICH GUIDELINES