It is very common for independent companies, private equity firms and venture capital companies to engage in the merger, acquisition or investment in FDA regulated companies. The assessment of these opportunities can be very complex, and in addition to detailed reviews of the business, financials and sales data, a thorough risk assessment of the target firms FDA quality compliance status and regulatory history should be included.. The FDA requirements and obligations for regulated companies and extensive and very complex and require an expert to review the available data and information, assess the state of compliance and determine if significant regulatory risk exists. A thorough regulatory and compliance assessment should be a standard part of any due diligence and the results taken into account prior to the final negotiations of any deal. From the standpoint of FDA compliance, EAS conducts efficient and effective due diligence assessments, assisting purchasers in understanding the regulatory risks, compliance gaps and potential investments in future corrective actions and improvements that may be required to avoid potentially harmful FDA actions.
From a general overview to a more detailed analysis, EAS expert consultants can provide third-party audits, regulatory assessments, product and documentation reviews, personnel interviews, and determine potential investment requirements in support of any business transaction related to an FDA regulated company.
EAS due diligence services include such activities as the assessment of the firm’s: GMP compliance, FDA regulatory status, SOPs and policies, manufacturing operations, complaint management, adverse events reporting, product status and approval, labeling compliance, etc.
Having EAS perform an FDA regulatory due diligence for any potential transaction will provide the investors with an unbiased assessment and a complete understanding of the state of compliance and potential regulatory risk, which is necessary for any successful merger, investment or acquisition.