Product and master data
Prepare product, location, partner, and master data before onboarding and validation begin.
Your situation · First commercial launch
Prepare for your first commercial shipment. Not a whole new serialization department.
Bring serialization technology, trading-partner connections, validation and agreed operational support together before launch. Established SoftGroup technology and specialist service providers help you plan the first shipment and the compliance work that follows.
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Be ready for the first shipment with a clear view of how compliance will run from day one.
Launch readiness
Put the people, processes and connections behind your first shipment.
Bring your technology, partner exchange and validation together with clear responsibilities for daily compliance, before commercial operations begin.
Application and regulatory connections
Configure the validated serialization application and the DSCSA exchange and reporting connections the launch requires.
Partner onboarding
Coordinate and test commercial data flows across CMOs, 3PLs, wholesalers, and other trading partners.
Quality and validation
Complete documented testing, SOPs, approvals, training, and release evidence for inspection readiness.
Compliance operations
Establish monitoring, verification, exception, alert, and escalation workflows for steady-state operations.
Governance and continuity
Clarify responsibilities for reporting, change control, support, and business continuity before go-live.
Technology with managed compliance
One technology foundation. The operational support your team needs.
Established SoftGroup technology supports serialization and regulatory connectivity. Specialist service providers can support the recurring compliance work your launch team needs.
Technology foundation: validated platform, regulatory connectivity, and governed serialized data.
Connected partner network: onboarding and tested data exchange across CMOs, 3PLs, wholesalers, and other trading partners.
Launch validation: documented testing, SOPs, approvals, training, and release evidence.
Operational coverage: monitoring, verifications, alerts, exceptions, and escalation.
Managed compliance: structured operational support for the recurring work around serialization.
Customer control: agree the responsibilities, approvals and reporting your team needs from day one.
Lifecycle readiness
Ready for launch. Built for what comes next.
Build for your first shipment with room to support new products, partners and markets as the business grows.
Build launch readiness without building the full specialist function
Put the technology, partner connections, validation, and operating responsibilities in place before the first commercial shipment.
- Establish DSCSA and partner readiness
- Define validation and operating responsibilities
- Create a clear path to commercial go-live
Keep operations aligned with the business
After launch, products, partner networks, and operational requirements may change. The model should be able to evolve without creating unnecessary disruption.
- Extend support for new products and trading partners
- Keep technology and operational responsibilities clear
- Adapt the level of managed support as requirements evolve
Beyond launch
Extend the same foundation as commercial operations expand.
Commercial operations
Move from readiness into steady-state monitoring, exception handling, evidence, and reporting.
New products and partners
Add trading partners and commercial complexity without rebuilding processes and responsibilities from zero.
Regulatory expansion
Extend into additional markets through AssureTrace’s existing regulatory connectivity and platform breadth.
Governed data foundation
Keep reliable, traceable serialization records as a foundation for future insight.
Proven foundation
Established technology for regulated operations beyond the first shipment.
Built on SoftGroup’s established platform and more than two decades of serialization experience, AssureTrace gives launch teams a proven technology foundation for regulated operations and growth.
SoftGroup technology supports 145 pharmaceutical customers.
Live regulatory connectors in the SoftGroup platform. Confirm coverage for your target markets during launch planning.
Launch FAQ
What launch teams need to know.
Do we need to build an internal serialization team before launch?
Not necessarily. Managed compliance can support operational work such as exception handling, partner-data coordination, validation support and reporting, while customer governance and accountability remain in place.
How do the technology and managed compliance work together?
SoftGroup provides the serialization technology. Your contracted service provider handles the agreed operational activities, with responsibilities and support defined before launch.
What must be ready before the first commercial shipment?
The application, product and partner data, regulatory connections, trading-partner onboarding, validation evidence, SOPs, escalation paths, and ongoing operating responsibilities.
Can the model support new markets after launch?
The platform supports regulatory connectivity across multiple markets. Your launch plan confirms which connectors and services are available for each market you want to enter.
What happens as products, partners, or operating needs change?
The same technology foundation can support additional products and partners as the business evolves.
Start with your launch
Make your first shipment the start of a manageable operation.
Align launch timing, partner connections, validation responsibilities, and the right level of managed support before commercial shipment.