07 — Third-Party Audit & Compliance Assurance
Independent technical and regulatory assurance partner.
OutcomeKMS Third-Party Audits — providing independent assurance to support informed decisions, regulatory readiness and confidence in your pharmaceutical and clinical operations.
- Audit types: BA/BE, clinical and manufacturing
- 3
- Audit types: BA/BE, clinical and manufacturing
- GCP, GLP and GMP frameworks
- GxP
- GCP, GLP and GMP frameworks
- Review, follow-up and closure verification
- CAPA
- Review, follow-up and closure verification
01
A risk-based, scientific approach
With experience across pharmaceutical development, clinical research and regulatory environments, KMS brings a risk-based and scientifically driven approach to every audit.
02
BA/BE & Bioanalytical Facility Audits
Comprehensive assessment of BA/BE centres and bioanalytical facilities covering study management, protocol compliance, subject management, sample handling, bioanalysis, documentation, computerized systems, data integrity, quality systems and applicable GCP/GLP and regulatory requirements.
03
Clinical Trial & CRO Audits
Independent evaluation of CROs, clinical sites and clinical research operations, including clinical trial conduct, GCP compliance, investigator oversight, informed consent processes, source documentation, safety reporting, monitoring, data management, essential documents and quality management systems.
04
Pharmaceutical Manufacturing Facility Audits
Risk-based GMP audits of API, pharmaceutical formulation and finished-product manufacturing facilities covering quality systems, manufacturing operations, validation, laboratory controls, utilities, facilities, warehousing, documentation, computerized systems and data integrity.
05
Regulatory & Quality Frameworks
Audits can be aligned with applicable requirements and expectations of US FDA, EMA/EU, MHRA, ICH-GCP, GCP, GLP, GMP and other relevant regulatory authorities and standards, based on the scope and intended market.
06
From Audit Findings to Quality Improvement
KMS delivers more than an audit report. Our approach focuses on identifying compliance risks, systemic gaps and potential inspection vulnerabilities, with practical recommendations to support effective CAPA implementation and sustainable quality improvement.
Our audit deliverables include:
- Independent and objective audit assessment
- Risk-based identification of compliance gaps
- Critical, Major and Minor observations
- Data integrity and quality-system assessment
- CAPA review and effectiveness assessment
- Detailed audit report with actionable recommendations
- Follow-up assessment and closure verification, where required
Start a conversation
Where does your programme stand?
Tell us the molecule, the dosage form and the market you are filing in. A programme lead will read it and reply with what we would do next.
Business enquiries: vasanthi@kmshc.com · +91 97898 75194V-23