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The Challenge

In the pre-commercialization phase, our biopharma client faced significant upheavals in its Accounting & Finance departments and was uncertain about its readiness for its inaugural year of 404b compliance. They sought to replace their existing SOX service provider promptly to ensure a seamless transition.


What We Did

  • Comprehensive Review: We conducted a detailed examination of the client’s manual controls, meticulously aligning them with the risks identified by their external auditor, WCGW (what can go wrong). Based on this assessment, we published extensive recommendations
  • IT Controls Evaluation: Similar scrutiny was applied to the client’s IT general controls and IT scope, ensuring a thorough evaluation of their control environment
  • Testing Procedures: Prior to the external auditor’s involvement, we conducted rigorous testing procedures to validate the effectiveness of the controls. Additionally, control owner testing was performed to enhance the quality and reliability of control performance
  • Active Engagement: We actively participated in regular meetings involving the client, external auditor, and ourselves to maintain transparency and inform all stakeholders about progress, issues, remediations, and timelines


Our Impact

  • Deficiency-Free Compliance: In our first year of engagement, the client received no deficiencies reported by management or their external auditor, showcasing the effectiveness of our approach
  • Enhanced Confidence: The client emerged from the first year of our partnership with a robust control environment, with control owners significantly more confident in their ability to perform controls and withstand the scrutiny of external auditors
  • Continued Partnership: Recognizing the value we brought to their compliance efforts, the client chose to retain RGP as their SOX compliance service provider for the subsequent year, further solidifying our ongoing partnership