Global regulations aren’t going anywhere.
Global regulations are looming and the desire grows to prevent counterfeiting, tampering, theft, and diversion. Now more than ever, companies must solve the serialization and track and trace dilemma to control the chain of custody in their supply chain.
Serialization and Traceability Consulting
We’ve helped some of the world’s leading pharmaceutical supply chain companies become compliant with serialization regulations while maintaining or improving operational efficiencies. Our experience includes larger complex organizations, to emerging biotech and biopharma, to virtual pharma companies.
Even with the best compliance procedures at work, changes in regulations means changes for your organization. We start by looking at the impacts of customer and government regulations to design a comprehensive serialization roadmap that is tailored to your existing procedures and overall corporate goals.
- Geographic Regulatory Assessment
- Serialization Pilot and Roadmap Design
- Technology Landscape Assessment
- DSCSA Compliance
Getting in compliance shouldn’t take all of your time. We specialize in putting your serialization plans into action through organizational and process improvements and technology planning.
- Cross-Functional Team Alignment
- Process Integration with 3PL, Warehouse, and CMO
- Track and Trace Vendor Selection
- Serialization Vendor Assessment
- Operationalization of Serialization Strategy and Processes
Serialization technology keeps getting better. We specialize in implementing best-in-class serialization technology to integrate with your existing landscape.
- Serialization Technology Integration
- Serialization Compliance Training
- Master Data Governance
- Validation Process Implementation
- Vendor and Third Party Change Management
- SAP Advanced Track and Trace for Pharmaceuticals (SAP ATTP)
What 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.