Serialization & Supply Chain Compliance Services

Ensuring compliance with global drug traceability regulations, such as the U.S. DSCSA (Drug Supply Chain Security Act) and the EU FMD (European Falsified Medicines Directive), is critical for pharmaceutical companies. At PRG, we offer comprehensive serialization program management customized to meet your specific regulatory needs, helping you navigate complex compliance landscapes and implement serialization solutions that enhance supply chain transparency, security, and integrity.

Our team partners with you from day one to develop and implement an optimal serialization strategy tailored to your operations. Whether preparing for DSCSA, EU FMD, or other global traceability standards, we ensure your serialization program meets current regulatory requirements, providing peace of mind that your supply chain remains fully compliant.

Partner Onboarding & Readiness

Serialization requires not just internal readiness but also close collaboration with your external partners, including contract manufacturers, wholesalers, and logistics providers. PRG's Onboard Partner Program ensures that we evaluate each of your business partners’ readiness and willingness to comply with regulatory requirements, performing thorough risk assessments to minimize disruptions in your supply chain.

L4/L5 System Integration & Validation

Our L4 System Validation services provide flexible solutions for testing, validating, and producing serialization data at the enterprise level. From ensuring proper data flow between line-level (L2/L3) systems to your central repository (L4/L5), our validation services cover every aspect of the process, ensuring compliance and operational continuity. We also empower you to maintain control over system updates, ensuring flexibility and scalability as your needs evolve.

Alert Management & Operational Support

Serialization doesn’t stop with implementation—it’s a continuous process. Our expert team offers Alert Management, Analysis, and Resolution services to ensure that serialization data is accurately reported and any issues are promptly addressed. From alerts generated during production to compliance reporting, we help you stay ahead of any potential disruptions in your serialization operations.

Data & Analytic Services

Data is at the heart of serialization and traceability. Our Data & Analytic Services leverage advanced analytics and digital transformation tools to turn your serialization data into actionable insights. From supply chain optimization to regulatory compliance tracking, we support you throughout your Data Transformation journey—from defining a data strategy to setting up Data Platforms as a Service (DPaaS).