US DSCSA Compliance Assessment

Drawing on Jennason’s 18 years of pharmaceutical serialization and U.S. Drug Supply Chain Security Act experience, the Jennason U.S. DSCSA Compliance Assessment provides manufacturers with a comprehensive, mock-audit-style evaluation of their DSCSA compliance program. Through structured data-gathering exercises, stakeholder interviews, document reviews, and realistic DSCSA compliance scenarios, Jennason evaluates the quality, effectiveness, and operational robustness of the manufacturer’s systems, policies, procedures, and controls against applicable DSCSA requirements. Upon completion of the assessment, Jennason delivers a comprehensive report that includes: - Identified compliance gaps and areas of potential exposure - Findings prioritized according to compliance and operational risk - Detailed, practical recommendations for mitigating each identified risk - Strategic considerations for strengthening the organization’s long-term DSCSA compliance program Jennason’s services are also available to support manufacturers in implementing the recommended mitigation actions. This support may include remediation planning, policy and procedure development, system and process improvements, stakeholder coordination, testing, training, and ongoing compliance advisory services. Manufacturers that complete the Jennason U.S. DSCSA Compliance Assessment are better prepared to respond confidently to FDA, state regulatory, and trading-partner audits. The assessment also provides a practical roadmap for reducing compliance risk, improving operational readiness, and incorporating DSCSA requirements into the organization’s broader compliance strategy.