In the private equity and trade buying space, regulatory change is the primary driver of market volatility. However, traditionally in M&A transactions, financial, legal and commercial considerations have taken precedence over regulatory considerations. Failure to perform robust regulatory / FDA Compliance due diligence is not an option in today’s regulatory environment and can lead to unknown liabilities materializing after the deal.
The benefit MEDVACON provides is very unique and the service we offer is critical during the due diligence phase. During this time, we conduct inspections and audits of the company’s FDA regulated systems that encompass warehousing, manufacturing, packaging, distribution, supply chain, all supporting computer systems, Quality Management Systems, etc. This work is crucial in assisting organizations focus on due diligence phase and in avoiding costly system flaws. This becomes especially critical (and more expensive) if these gaps are found during an FDA audit. By proactively identifying these issues, acquiring company solidifies a strong financial position through risk management. This approach and work also provide the company with a detailed report outlining the critical issues requiring attention. In addition to conducting the assessment, MEDVACON provides the expertise to help the organization remediate any gaps and achieve compliance.
By ensuring a robust approach to regulatory due diligence, firms can gain a host of benefits. Throughout the process of an acquisition and while taking into consideration the factors mentioned above, firms should constantly reflect on whether their due diligence process (and the deal itself) facilitates: