PHARMACEUTICAL REGULATORY AFFAIRS
Regulatory Due Diligence
Structured regulatory risk assessment to support licensing, acquisitions and portfolio decisions.
SERVICE 03
Document-based regulatory assessment
We assess the available marketing authorisation and dossier documentation, approval history, post-authorisation commitments and other regulatory information relevant to the transaction or product portfolio.
Risk identification and prioritisation
Findings may be classified as Critical, Major or Minor using project-specific, agreed assessment criteria. These categories are an analytical framework for the assignment and must not be confused with official authority classifications.
Decision-focused reporting
We present evidence-based findings, document limitations and recommended next steps to help buyers, licensors and other stakeholders understand regulatory exposure and remediation requirements.
Typical support activities
- Regulatory dossier and authorisation status review
- Identification of missing or inconsistent documentation
- Review of lifecycle commitments and regulatory history
- Project-agreed severity classification and risk register
- Due diligence report with proposed follow-up actions
Services and deliverables are subject to a project-specific scope of work and the relevant regulatory framework.
DISCUSS A PROJECT
Need specialist regulatory affairs support?
Get in touch to discuss the regulatory scope and documentation requirements for your project.