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Creating a SOX Compliance Program for a Newly Public Pharma Company​

Creating a SOX Compliance Program for a Newly Public Pharma Company​

A newly public pharmaceutical company engaged us to create a program for compliance with Sarbanes-Oxley 404. The project resulted in the company having a strong foundation for regulatory compliance and a successful first-year audit.​

Challenge

A newly public, pre-revenue biopharmaceutical company engaged SolomonEdwards to develop its Year 1 program for compliance with Sarbanes-Oxley 404. The client wanted to ensure it had a stringent compliance program capable of ongoing annual assessments and external auditor reliance.​

Solution

Drawing upon industry acumen and best practices, we provided a comprehensive SOX compliance program to both improve operational efficiency and meet regulatory standards, thereby securing a strategic advantage for the firm during the pivotal early stages of public investment. Key elements of the program included:​

  • Risk Assessment: Execution of a SOX risk assessment including IT, fraud and business processes, inclusive of significant account mapping​
  • Documentation: Development and maintenance of documentation over significant classes of transactions and IT control frameworks​
  • Process Validation: Comprehensive walkthroughs of significant processes and key controls​
  • Control Testing: Interim and year-end testing and preparation of workpapers for key financial, IT, and entity-level controls​
  • Reporting: Regular updates to the Audit Committee, encapsulating the status of the SOX Compliance Program​
  • Final Reporting: Delivery of a comprehensive management report and facilitation of interactions with external auditors

Outcome

SolomonEdwards’ development of the company’s SOX compliance program enabled strict adherence to regulatory standards while also enhancing operations. The compliance program has given the company a solid foundation for ongoing compliance and for external audit reliance on management testing. These efforts also enabled the company to successfully complete the Year 1 SOX 404 assessment, develop an efficient and robust SOX compliance program, and identify recommendations for future optimization efforts.​

Industry

  • Healthcare
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