Third Party/External Audits

​

1. Third-Party and Vendor Audits: Independent auditing of external partners such as Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), analytical testing laboratories, and raw material suppliers to ensure they meet quality standards and regulatory requirements.

 

2. GxP Auditing: Comprehensive audits covering all GxP areas, including GCP (clinical trials), GMP (manufacturing), GLP (laboratory practice), GVP (pharmacovigilance), and Computer System Validation (CSV).

 

3. Regulatory Inspection Preparedness: Conducting mock inspections (Pre-Approval Inspections (PAI) readiness) to identify gaps and prepare client personnel for actual inspections by health agencies like the FDA, EMA, and MHRA.

 

4. Gap Analyses and Remediation: Performing detailed assessments of a company's quality management systems and processes to identify compliance gaps, followed by support in developing and implementing Corrective and Preventive Actions (CAPA).

 

5. Quality Management System (QMS) Optimization: Designing, implementing, and optimizing GxP-compliant quality systems and assisting with the creation and documentation of Standard Operating Procedures (SOPs).

 

6. Clinical Trial Site Audits: Auditing clinical trial sites to ensure data integrity and adherence to study protocols, GCP, and all applicable regulatory requirements.

 

7. Data Integrity Audits: Specialized audits to ensure the accuracy, completeness, and reliability of all data generated and handled within the organization.

 

8. Training: Providing training to staff on current regulatory requirements and best practices in quality assurance.