Validated endotoxin testing services partners
Partner with CMD for validated, pharmacopoeial-compliant endotoxin testing services supporting product release, method validation and complex biopharmaceutical matrices. Our Cardiff-based laboratory operates under ISO 9001 and UKAS accreditation (No. 23137), delivering precise, audit-ready results for regulated environments.
Why Partner with CMD?
CMD operates as:
A UKAS accredited testing laboratory No. 23137
An organisation certified to ISO 9001 (BSI certificate FS749484)
Our accreditation scope covers bacterial endotoxins testing performed in accordance with harmonised pharmacopoeial methods. As validated endotoxin testing services partners, we provide documentation suitable for regulatory submission, audit review and batch release support.
We support:
Companies scaling manufacturing capacity
Sponsors preparing for inspection
Teams validating new formulations
Developers addressing product-specific interference
Our approach combines technical expertise, regulatory understanding and pragmatic turnaround times.
Validated Endotoxin Testing Services
Using the PYROSTAR™ line of endotoxin-specific LAL reagents from FUJIFILM Wako Chemicals U.S.A. Corporation, CMD offers:
Routine Endotoxin Testing
Validated bacterial endotoxins testing of liquid pharmaceutical products for release and stability studies.
Method Development & Validation
Development and validation of product-specific endotoxin test methods, including inhibition/enhancement studies in accordance with pharmacopeial requirements.
Low Endotoxin Recovery (LER) Studies
Assessment and investigation of time-dependent endotoxin masking phenomena in complex biopharmaceutical matrices.
Each study is designed to generate precise, reproducible and regulator-ready data.
What We Test
Our validated endotoxin testing services partners support a broad range of regulated sample types, including:
Injectables and infusions
Biologics and biosimilars
Nanoparticle and adjuvant-containing formulations
Dialysis fluids
Medical device rinsates
We routinely handle complex, coloured and interference-prone matrices requiring tailored validation strategies.
A strategic testing partner —
not just a laboratory
As validated endotoxin testing services partners, CMD does more than process samples. We:
Advise on pharmacopeial strategy
Support audit and inspection readiness
Assist with troubleshooting interference
Provide defensible validation reports
Maintain clear communication throughout study execution
Our collaboration with FUJIFILM Wako Chemicals U.S.A. Corporation ensures access to endotoxin-specific LAL reagents recognised for their performance and regulatory acceptance.
Looking for a validated endotoxin testing services partner?
Organisations across the UK, Europe and North America rely on CMD as their validated endotoxin testing services partners when accuracy, compliance and turnaround matter.