November 2024

CMC Due Diligence Common Stumbling Blocks

Conducting thorough CMC due diligence in the pharmaceutical industry is essential to avoid pitfalls that can jeopardize the success of mergers, acquisitions, and licensing agreements. Here are some common stumbling blocks to watch out for:

1. Neglecting the CMC Aspect: Ignoring CMC can lead to challenges like delayed regulatory approvals and compromised product quality, ultimately affecting patient
safety.

2. Underestimating Emerging CMC Risks: Proactively address complex CMC risks, including continuous manufacturing technologies, reliance on CDMOs (Contract
Development and Manufacturing Organizations), and supply chain cybersecurity threats.

3. Lack of Technical Expertise: Ensure the due diligence team has sufficient technical expertise to resolve issues and interpret data accurately, especially for complex
biopharmaceutical processes.

4. Overlooking Regulatory Compliance: Failing to address non-financial risks like potential regulatory compliance and CMC guidance an lead to regulatory
clinical holds, approval delays and denials, penalties and reputational damage.

5. Supply Chain Fragility: Evaluate global supply chain vulnerabilities early, considering factors like geopolitical instability, raw material shortages, and dependence on single-source suppliers.

Being aware of these common stumbling blocks can help you navigate the complexities of CMC due diligence more effectively. By proactively addressing these issues, you can safeguard your investments and ensure the successful delivery of high-quality, safe, and effective products to patients. For more insights on CMC due diligence, stay updated with the Windshire blog. For specific due diligence or audit needs, contact Windshire or Labshire for expert guidance.