Pharmaceuticals
Safeguarding Medicines, Empowering Missions
Pharmaceutical Handling – Precision, Compliance, and Global Traceability
Managing pharmaceutical products is one of the most critical responsibilities for humanitarian and healthcare supply chains. Products must be handled with precision, tracked with accuracy, and documented with full compliance to strict regulations. HELM was designed with these requirements in mind. It delivers end-to-end capabilities for receiving, tracking, valuing, and distributing pharmaceuticals across both domestic and international supply chains.
Compliance from the Start
HELM is fully compliant with the FDA Drug Supply Chain Security Act (DSCSA). This includes all of the latest mandates for serialized product tracking throughout the distribution process. From the very first point of intake, HELM ensures that products can be identified and followed through every step until they reach the final recipient.
Inbound Receiving and Validation
HELM acts as a proxy AS2 endpoint, which allows it to receive EPCIS XML data files directly from donors and vendors via AS2. This enables the system to validate every incoming product against the provided serialization data.
Products can be received at any level of detail. A shipment may arrive as an SSCC-coded pallet, as cases of product, or even down to individual bottles of medicine. HELM can validate and process them all.
HELM also integrates in real time with First Databank (FDB). This connection ensures that every pharmaceutical product is linked to a comprehensive set of information, including NDC codes, classifications, packaging, units of measure, formulations, ingredients, uses, and cost history.
Because of this integration, HELM can even create new items automatically. When a warehouse worker scans a GTIN barcode, the system immediately pulls the correct information from FDB and sets up the product without interruption. This makes the receiving process faster, more accurate, and far less error-prone.
Serialization and Traceability
Every pharmaceutical product in HELM is license plated as soon as it is received. This step establishes the foundation for end-to-end traceability.
Serialization data is maintained at all levels of handling. HELM supports aggregation and de-aggregation, so products can be tracked whether they are managed as full pallets, broken down into cases, or picked at the bottle level.
This capability ensures that organizations always know where their products are and how they have been handled. It also provides the detailed records required to support sensitive processes such as product recalls or destruction orders.
Valuation and Audit Trails
Valuing donated pharmaceuticals is often a difficult and time-consuming process. HELM simplifies this task with its automated valuation features.
Through its FDB integration, HELM can assign accurate, consistent values to products the moment they are received. Every valuation action is captured in a complete audit trail, ensuring that donor reports, financial records, and regulatory documentation are fully supported.
This creates confidence that product values are not only correct but also traceable back to an authoritative data source.
Order Building and Distribution
When it comes to order building, HELM gives organizations full flexibility. Products can be managed and picked at any level — pallets, cases, bottles, or serialized units.
HELM also supports mixed orders. This means organizations can build shipments that contain a blend of donated pharmaceuticals, purchased goods, and other product types. The system enforces all donor rules and compliance checks automatically, so shipments are always aligned with regulations and donor intent.
During the picking and packing process, HELM supports advanced workflows such as aggregation, de-aggregation, and custom skid building. This gives teams the ability to create orders that meet the exact needs of their partners and programs.
Shipping and Downstream Compliance
At the time of shipment, HELM generates all of the required logistics documentation for transportation and compliance.
In addition, HELM creates the downstream EPCIS XML files that are required for the next party in the supply chain. This ensures that serialization and traceability do not stop at the warehouse door, but continue seamlessly throughout the broader distribution network.
Global Reach and Last-Mile Assurance
HELM is designed for global operations. In addition to meeting FDA DSCSA requirements, it also supports emerging frameworks in the EU and other international markets. This gives organizations confidence that they can comply with regulations no matter where their products travel.
With license plating and traceability built in, HELM can follow pharmaceutical products all the way to their final destination. Whether shipments are delivered to a national partner, a field office, a local clinic, or directly to last-mile recipients, every product remains fully accounted for.
The Result
HELM combines nearly four decades of logistics expertise with advanced pharmaceutical compliance features. The result is a system that ensures pharmaceutical products are received accurately, valued consistently, stored safely, and shipped with full compliance.
From intake to last-mile distribution, HELM provides the precision, traceability, and accountability needed to manage life-saving medicines in some of the most challenging environments around the world.
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