Regulatory

Regulatory

ACHIEVE REGULATORY AUTHORIZATIONS

  • Clinical Regulatory Affairs

AUDIT SERVICES

Assessment of Current Practices and Proposals and Guidance in Improvements of AP’s Clinical Research Activities-Asia and Global

  • Assessment of:
    • CP Site Systems Inspection
    • GCP Protocol-Specific Audit
    • Inspection of safety and well-being of consumers
    • Data collection oversight
    • Review of ethics committee approvals and Ensuring Regulatory Compliance
    • Bioethics Advisory Committee
    • FDA, R&D Office – Domain Specific Review Boards
    • Resolving Data Queries * Source data verification
    • Corrective action and preventive action plan
  • Recommendations for Standardization & Alignment of AP’s Asia and Global Research Activities:
    • Standard Operating Procedures
    • QA/ QC system, procedures and documentation
    • Source documentation, Case Report Forms
    • Informed Consent forms
    • Study Product or Device handling procedures and documentation
    • Study Protocol, deviations and change logs
    • Review of Subject recruitment system and subject information collection
    • Identification of gaps Asian compared with the US system: patient safety

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