Compliance and system consistency

Gap analysis between current documentation (batch manufacturing/analyzing records or procedures) or systems versus practices, standards, regulations, marketing authorization files, remarks and observations from previous inspections to identify action plan implementation, and follow-up. Update documentation and marketing authorization files, support changes to current practices, and provide training.

Audit for due diligence or compliance

Audit for due diligence

Before an acquisition, provide an audit of Modules 1, 2.3, 2.7, 3, and 5. Assess prepared documentation or equivalent documentation (core dossier), and identify gaps based on knowledge of the regulatory environment. Drawing on expertise across the PLG organization, PLG teams can perform a complete audit of Modules 1 to 5.

Gap analysis for dossier consistency or compliance with applicable regulation

  • Gap analysis between the approved dossier and the technical documentation currently in use at the manufacturing site
    (analytical procedures, manufacturing instructions)
  • Gap analysis between the approved dossier and the current regulation (ICH, EU, US, etc.)

Risk assessment report

  • Elemental impurities: Evaluation of potential contaminants in accordance with ICH Q3D, including genotoxicity, toxicity, and risk assessment. Propose a risk-based control strategy to limit elemental impurities in the drug product.
  • Nitrosamines: Coordination and liaison with suppliers, assessment of documentation, and risk-based assessment to determine the formation or presence of nitrosamines in the drug product