Serialization and traceability requirements impact the entire operating model from supply chain and IT to quality and regulatory operations.
As global regulations mature, organizations are shifting from implementation to ongoing operations, with a focus on managing alerts, data integrity, and partner interactions. Maintaining compliance while ensuring visibility and control across the supply chain is critical to mitigating risk.
Serialization and Traceability Consulting
We help life sciences organizations design, implement, and operationalize serialization and traceability capabilities across their entire operating model. Our experience spans global pharmaceutical companies, emerging biotech, and virtual pharma organizations.
Strategy, Assessment, and Roadmap Development
We evaluate your current state landscape and define a roadmap aligned to regulatory requirements.
- Geographic Regulatory Assessment
- Serialization Pilot and Roadmap Design
- Technology Landscape Assessment
- DSCSA Compliance Audit
Process Design and Operational Execution
We help organizations move beyond compliance to establish sustainable, scalable serialization operations.
- Cross-Functional Team Alignment
- Process Integration with CMOs, 3PLs, and Warehouses
- Operationalization of Serialization Strategy and Processes
- Serialization Compliance Training
Technology Selection, Implementation, and Optimization
We support the selection, implementation, and enhancement of serialization platforms within your broader IT ecosystem.
- Serialization Technology Integration
- Track and Trace Vendor Selection and Assessment
- Master Data Governance and Data Integrity
- Validation and GxP Compliance Support
- Vendor and Third-Party Change Management
Platform Expertise: SAP ATTP and TraceLink
Our team brings deep expertise across leading serialization platforms, enabling seamless integration, configuration, and ongoing optimization.
- TraceLink network onboarding, alert management, and data exchange optimization
- SAP ATTP implementation, integration, and support
- Platform configuration, enhancements, and issue resolution
- Alignment of platform capabilities with business processes and regulatory requirements
TraceLink Consulting
Curious about digitalizing your end-to-end supply chain? Clarkston’s TraceLink consultants bring deep life sciences industry expertise to help you navigate your supply chain orchestration. We offer an integrated set of supply chain services that enable clients to keep production running smoothly.
Learn MoreWhat Our Clients Say
Global Serialization Director
Clarkston didn’t bring consultant jargon or templates to the table. Rather, a bespoke consultancy firm that delivered knowledgeable consultants.
We’ve helped the world’s largest pharmaceutical companies to develop a serialization strategy, produce global templates to roll-out to specific countries, and improve operational excellence through technology improvements. The result was a fully validated solution to address FDA compliance regulations, and the removal of silos in the business, allowing them to operate in a global manner. We’d love to discuss how our team can partner with your organization.
