Quality Assurance
A quality system that is compliant on paper and in practice, with audit readiness built in.
ICH Q7, Q9, Q10; 21 CFR 210/211, EU GMP, Schedule M
How we can help
- GMP gap assessment and mock inspection (FDA, EU, WHO, Schedule M)
- QMS build or remediation: change control, deviation, CAPA, complaints, APR
- Supplier and vendor qualification, audit programmes, remote audits
- DMF and dossier quality sections; responses to inspection observations
- Internal auditor training and quality-culture programmes