ISO 9001:2015 certified quality
We hold our own work to the standards we help clients meet — backed by a certified quality system and auditors qualified to global GxP frameworks.
ISO 9001:2015
Our own consulting and audit services are delivered under a certified quality management system, ensuring consistency, traceability and continual improvement in everything we do.
Qualified lead auditors
Our auditors are qualified and experienced against WHO, EU GMP, US FDA and PIC/S expectations, with credentials appropriate to each GxP discipline.
Verifiable audit-report database
Audit outputs are recorded in a verifiable database, enabling shared audits and giving clients confidence in the provenance of every report.
Global regulatory coverage
We work to the regulatory frameworks of the major markets — FDA, EMA, MHRA, WHO and rest-of-world — across the full GxP spectrum.
Frameworks We Work To
Global standards across every GxP discipline
- EU GMP (Parts I & II, Annexes)
- US FDA 21 CFR 210/211
- ICH Q7–Q12
- ICH Q9 (QRM)
- ICH Q10 (PQS)
- EU GMP Annex 1
- EU GMP Annex 11
- 21 CFR Part 11
- GAMP 5
- ALCOA+
- ICH E6 (GCP)
- EU GVP Modules
- OECD GLP
- EU GDP
- ISO 13485
- ISO 14971
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