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M&A, Due Diligence and Insurance Assessments

The assessment of a firm’s compliance status is complex, requiring expert review of available data and determination of whether a significant regulatory risk or concern exists.

EAS conducts efficient and effective FDA due diligence assessments and third-party audits, identifying any regulatory risks, compliance gaps, and, whether appropriate steps and corrective actions have been taken. By identifying any required corrective actions and improvements to avoid potentially harmful FDA actions, a clearer picture of a firm’s regulatory risks comes into focus.

From a general overview to a more detailed analysis, EAS expert consultants provide third-party audits, regulatory assessments, product and documentation reviews, personnel interviews, and more to assess potential risk and offer a fair regulatory determination of the company in question.

Having EAS perform a regulatory due diligence assessment will provide an unbiased view and a complete understanding of the state of compliance any potential regulatory risks.

GMP compliance

FDA regulatory status

SOPs and policies

Manufacturing operations

Complaint management

Adverse events reporting

Labeling compliance

And more

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