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Building and Scaling a SOX Compliance Program for a Growing Biopharmaceutical Company
A newly public, pre-revenue biopharma company faced the challenge of establishing a Sarbanes-Oxley (SOX) 404 compliance program while navigating the demands of IPO readiness and early-stage operational growth. Without a dedicated internal team to manage the complexities of financial reporting compliance, the company needed a reliable partner to implement a compliant control environment and support the evolving regulatory landscape.
We were initially engaged to lead the design and execution of the company’s SOX 404 compliance program, beginning in its first year as a public company. Our team developed foundational compliance processes that included risk and fraud assessments, controls documentation, walkthroughs and testing of key financial, IT and entity-level controls. We created detailed planning documentation, mapped assertions to financial statement accounts, and maintained regular communication with the company’s leadership and Audit Committee throughout the engagement.
We continue to provide full-year SOX support to the client, deploying a consistent team of subject matter experts in business processes and IT. In addition to executing interim and year-end control testing, our team has continued to adapt the compliance program to the company’s evolving structure.
Beyond SOX compliance, new needs emerged related to SEC reporting complexities and tax provision support—leading to an expanded, multiyear partnership. During the company’s annual 10-K filing, we were called upon to assist with segment reporting, quickly connecting management with our technical accounting specialists to deliver a timely, audit-ready memo. When the company pursued a PIPE (Private Investment in Public Equity) financing agreement, our team again provided technical accounting support that addressed the complex accounting and valuation issues associated with the transaction. We worked directly with the company’s external auditors and their specialists to address all significant issues and alleviate the burden on the company’s accounting team. Our tax specialists continue to prepare the company’s annual tax provision and supporting documentation.
From IPO readiness through year-over-year audit cycles, our team established and matured a sustainable compliance framework that has evolved with growth and regulatory requirements. In its most recent fiscal year, the client achieved a reduction in control deficiencies of 36%, which demonstrates measurable improvement in process maturity and audit readiness. The client continues to engage our firm across multiple functions, reflecting a trusted, ongoing partnership built on responsiveness, subject matter expertise and operational impact.