Pharmaceutical customers
Supported by SoftGroup technology.
Managed pharmaceutical serialization compliance, built on established SoftGroup technology. Specialist service providers handle agreed daily operations, partner coordination and controlled changes, while your team retains oversight and regulatory accountability.
Switching providers, preparing your first launch or managing growing compliance demands? Start with the outcome you need, then explore the technology and specialist support behind it.
Assess how the FDA’s 12-digit NDC format affects item masters, labels, partner data, and your serialization stack before the transition becomes urgent.
Start with your existing connections, then plan the change using a nine-stage migration methodology with six control gates.
Put DSCSA technology, partner connections, validation, and managed compliance in place before the first commercial shipment.
PROVEN TECHNOLOGY
AssureTrace connects specialist managed serialization services with SoftGroup’s established technology. The service model is new; its technology foundation and delivery experience are not.
Supported by SoftGroup technology.
In SoftGroup’s established customer base.
Customer migrations from other providers completed by SoftGroup over three years.
These figures describe the established SoftGroup business behind the technology used by AssureTrace.
Explore our technology foundation →Tell us where you operate and which activities your team needs handled. Explore service-provider options and clarify who delivers each part before you commit.
Explore service delivery →Assess your trading-partner connections, protocols and dependencies to understand what can stay connected and what needs to change.
Follow a structured method from qualification and design through testing, controlled cutover and the agreed operating model.
Use defined readiness checks, approvals and evidence at critical decisions, with criteria tailored to each project.
Apply the same migration framework across supported markets while adapting technical, regulatory and contractual requirements.
LOOKING AHEAD
Today’s compliance work creates records that could help specialists investigate exceptions and prepare evidence in future. Customer-facing intelligence capabilities are not currently available.
Explore the data foundation →An interactive summit for first-time launch teams and commercialization leaders, focused on the practical decisions behind preparing for and executing a first commercial launch.
Meet AssureTrace in Boston, 2–5 November, to discuss second-generation serialization management, controlled switching and ongoing DSCSA operations.
Tell us what is taking up your team’s time, where your current setup falls short and what needs to change. We’ll help you explore the next step.