The FDA requirements and obligations are extensive and complex, requiring expert review of available data, assessment of the state of compliance and determination if a significant regulatory risk exists. Any due diligence should include a thorough regulatory and compliance assessment, with the results considered as part of the final negotiations of any deal. EAS conducts efficient and effective due diligence assessments on FDA compliance, 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.