After more than a decade of policy development, the FDA’s focus has shifted to auditing and enforcement. Manufacturers are now under the microscope, and outdated or inconsistent SOPs won’t cut it. Recent Form 483 observation letters confirm that the FDA is actively scrutinizing DSCSA compliance—particularly around serialization systems and documentation.
Two Labs has been leading the way in DSCSA strategy and serialization compliance for years. Let’s talk about getting your SOPs, and your team, audit-ready.
Karuna Therapeutics – A Bristol Myers Squibb Company, a cutting-edge neuroscience company, was in the midst of preparing for a critical U.S. product launch when it encountered the complex regulatory requirements of DSCSA compliance.
Exelixis, a leader in biopharmaceutical innovation, is dedicated to developing therapies that meet critical medical needs. However, as DSCSA requirements and regulations continued to evolve, Exelixis encountered obstacles in maintaining a compliance framework that could keep pace with its rapid growth.
Through every step of the commercial journey, Two Labs is your partner in driving success.
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