December 2024

CMC Due Diligence Best Practices

Due diligence is crucial in the pharmaceutical industry for mitigating risks and ensuring success, especially during mergers, acquisitions, and licensing agreements. Windshire has deep expertise in CMC due diligence, and here are some of our best practices.

1. Precision and Accuracy: Conduct a rigorous and detailed due diligence process, scrutinizing CMC assets to ensure the proper deal structure and terms.
2. Multidisciplinary Team: Assemble a team with diverse expertise across clinical, regulatory, commercial, and CMC domains. Include experts in environmental sustainability and digital health integration to uncover hidden risks or opportunities.
3. Cross-Functional Communication: Maintain open and consistent communication across all functional teams to ensure alignment and a holistic understanding of potential issues, including supply chain vulnerabilities and cybersecurity threats.
4. Direct Access to Key Management: Establish direct access to key decision-makers within the target company to evaluate current operations and investigate its Environmental, Social, and Governance (ESG) policies.
5. Investigative Approach: Go beyond surface-level checks to identify hidden risks, such as regulatory non-compliance and potential future vulnerabilities in the supply chain.

Following these best practices can significantly enhance the effectiveness of your CMC due diligence process, ensuring a thorough evaluation and successful outcomes. Stay tuned for our next post on common stumbling blocks in CMC due diligence. For specific due diligence or audit needs, contact Windshire or Labshire for expert guidance.