Regulatory audits by authorities such as PMDA, EMA, and US FDA are becoming increasingly rigorous, with heightened scrutiny on pharmacovigilance systems, data integrity, and SOP adherence. Japanese pharmaceutical companies must not only maintain global compliance standards but also navigate the unique requirements of Japan's regulatory landscape.
Venture Out Japan offers a comprehensive Audit and Inspection Readiness service specifically designed to prepare Japanese pharma companies for both domestic and international audits.
Our Services Include
- Mock Inspections simulating real PMDA, EMA and FDA audits, led by consultants with audit participation experience
- Gap Analysis covering system configurations, procedural documentation, safety case processing, and compliance traceability
- Corrective & Preventive Action (CAPA) Planning aligned with global GVP/GCP standards and local Japanese expectations
- Review and optimization of Standard Operating Procedures (SOPs) for alignment with current regulatory updates
- Readiness assessment for systems like Argus, LSMV, and Veeva Vault Safety
- Preparation of teams for auditor interviews and document presentation
Why Choose Venture Out Japan
- Deep familiarity with PMDA inspection practices and documentation norms
- Proven experience supporting both Japanese HQs and global affiliates
- Tools and checklists tailored for pharmacovigilance, clinical trials, and post-marketing surveillance (PMS)
- Efficient and non-disruptive approach, ensuring minimal operational downtime during preparation
Our goal is to build confidence, reduce risk, and ensure audit success—whether it's a routine inspection, triggered audit, or global HQ compliance check.