Track & Trace
The global pharmaceuticals industry is in the middle of major changes with regulatory requirements to improve supply chain security and patient safety.
All pharmaceutical companies should design their strategies, and get to project execution quickly, as the deadlines for these legislations are approaching fast or recently became effective. Supply Chain Wizard’s team of expert consultants will partner with your organization to provide complete end-to-end Serialization (Track & Trace) support you need to achieve cost-effective compliance.
With many project experiences for US DSCSA, EU FMD, Russia, Turkey, India DGFT, Brazil ANVISA, Saudi Arabia, S. Korea and other countries, we are your global Track & Trace partner to keep you compliant.
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Serialization Regulation Database - Global Regulatory Requirements updates
Regulations
A single, always‑current regulatory database captures global serialization mandates and timeline shifts, ensuring that global regulations, timelines, and data standards remain visible and actionable. This enables proactive adjustments to artwork, data paths, and lead-time planning, shifting compliance from reactive firefighting to strategic readiness.
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Serialization Landscape Evaluation
Vendor Selection
An accelerated, end-to-end diagnostic that reveals how your serialization systems, data flows, vendor integrations, and organizational practices collectively support or undermine compliance readiness. With targeted benchmarking and risk mapping, business-critical gaps are surfaced quickly and you will get the expert support to create a cost-effective strategy for compliance or high-impact interventions aligned with your global regulatory roadmap.
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RFP - Serialization L1-5 Vendor Selections
Vendor Selection
A focused service where serialization vendors, ranging from line-level equipment to enterprise software are selected based on scalability, interoperability, and total cost of ownership. Capabilities are benchmarked, vendor demos are conducted, and proposals are validated to deliver clear recommendations aligned with regulatory mandates and long-term operational goals
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Serialization Turnkey End to End Implementation and Compliance
Implementation
A fully managed solution spanning line‑level equipment integration through L5 data exchange designed for seamless global compliance and uninterrupted operations. From vendor coordination to operational stabilization, system validation, and compliance documentation, this service ensures serialization mandates are met efficiently across all markets.
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Serialization Partner Onboarding (CMOs, 3PLs, Specialty Distributors)
Implementation
A structured onboarding program built to accelerate partner readiness through centralized coordination, SOP standardization, data exchange validation, and real-time tracking tools. Clear onboarding playbooks, milestone dashboards, and hands-on support ensure consistent compliance across even the most complex global partner networks.
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IT Connectivity to External Partners
Implementation
A comprehensive integration service that establishes secure API connections and message-level validation between your ERP, MES, and serialization platforms and external partners. Standardized protocols, rigorous testing workflows, and governance mechanisms ensure data integrity and real-time compliance across your global partner network.
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Aggregation Upgrades L1-5
Implementation
Retrofitting lines and databases to be able to not only handle serialized printing but also parent‑child relationships along with respective data transfer requirments. Often accompanied by automation such as cost‑saving case packers or palletizers.
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Serialization CMO Site Readiness Checks/Visit
Implementation
In person site visits are highly beneficial for identifying the core and extended capabilities of Contract Manufacturing and Packaging Organizations. With a CMO readiness check and visit, you can streghten a long lasting business relationship ensuring all product requirements are met. Our auditors verify equipment, processes, documentation, and data exchange at each CMO, providing documented assurance that outsourced batches will pass regulatory reviews.
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Global Serialization Standardization Programs
Implementation
Business Landscapes may change, such as part of a merger or acquisition of an additional site. Achieve standardization by consolidating disparate processes, vendors, and code schemas into a unified global architecture—unlock operational efficiency and ensure one version of the truth across extended networks. This harmonized structure also simplifies data governance, accelerates compliance rollout, and supports scalable serialization deployment.
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Serialization Level L1-5 Validation
Validation
Every layer of serialization is rigorously validated from code print accuracy to EPCIS message integrity, resulting in audit-ready documentation that keeps regulators confident and shipments compliant. Quality is assured at every level, reducing risk and ensuring operational continuity.
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Serialization Operational Support
Daily Serialization Support
On‑call experts resolve alert spikes, rework requests, serial number verification requests and data mismatches before they snowball into quarantine or recall events, freeing your ops team to focus on throughput.
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EU FMD Alert Management/National Hub Communication
Daily Serialization Support
Alerts are triaged, investigated, and promptly closed at scale, ensuring national hub KPIs remain on track and product blocks are avoided. A robust hub communication process, case handling protocols, and compliance oversight keep operations smooth and customer confidence intact.
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Computerized System Validation Reports
Daily Serialization Support
Our GAMP‑5–aligned validation reports confirm that computerized systems from serialization platforms to ERP integrations are fully fit for intended use. By delivering structured documentation against critical compliance requirements, this service satisfies inspectors while protecting patient safety and minimizing disruption to IT operations.
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TraceLink Release Management
Daily Serialization Support
L4/5 Solution TraceLink is a multi-client environment, hence new software releases could effect daily operations. The Release Management Service evaluates the very many and frequent release notes against you business processes for potential impact, and if deemed necessary, test script are created and provided. This documentation is valuable to Quality and it guarantees computerized validated systems with adequate documentation at all times.
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Serialization Performance Management
Performance Management
While functional and business requirements are often fulfilled, reporting requirements may fall behind in the Serialization Landscape. Dynamic dashboard can bridge this gap, by connecting you your L1-5 systems, including data transfer files, creating valuable overviews about product movement, data transfer, data inconsitencies and others, allowing for root cause analysis and therefore overall improvement operational metrics on the line, site or in collaboartion with your CMOs.
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Serialization Trainings/Certifications
Training
Role-based courses develop plant, warehouse, and quality teams into confident serialization owners, reducing human-error rejects and minimizing audit findings. Practical, tailored training builds compliance readiness and operational excellence across your supply chain.
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TraceLink Specific Operational Trainings
Training
Hands-on, scenario-based sessions fast-track user adoption, reduce support requests, and maximize the value gained from every new TraceLink feature ensuring your investment delivers full ROI.
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Medical Device US Tracking Requirements
Medical Device
Helping you navigate the FDA’s unique device identification (UDI) mandates, ensuring your medical devices remain fully compliant, traceable, and audit-ready for the US market.
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Medical Device EU Tracking Requirements
Medical Device
Keeping you ahead of EU MDR requirements by simplifying UDI compliance, EUDAMED registration, and device traceability, safeguarding your European market access and patient safety.
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Medical Device Tracking Implementation
Medical Device
Efficiently implementing robust medical device tracking solutions, aligning people, processes, and technology to enhance compliance, data accuracy, and operational efficiency.
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Medical Device IT Setup and Data Transmission to Respective Hubs
Medical Device
Secure and reliable IT infrastructure is established to enable seamless data transmission of medical device information, ensuring timely, compliant communication with global regulatory hubs. System validation, data integrity, and adherence to both US and EU reporting standards are prioritized to support ongoing regulatory readiness.
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