Aperigon stands up Microsoft Dynamics 365 for biopharma companies approaching their first commercial launch — finance, supply chain, and serialization, with 21 CFR Part 11 validation included, live before your launch date.
You've run on R&D accounting and a clinical supply chain. A first commercial launch changes the requirements overnight: revenue recognition, gross-to-net, serialization, 3PL and CMO orchestration, and a first FDA inspection as a commercial company. QuickBooks and entry-level ERP won't carry any of it — and the clock is already running.
First-time commercial revenue, gross-to-net, chargebacks and rebates, and investor- or public-company-grade reporting on a lean team.
Your first commercial GxP inspection, with Part 11 and data integrity across a supply chain you mostly outsource.
Orchestrating contract manufacturing, 3PL, DSCSA serialization, and cold chain without owning a plant.
Standing up a commercial-grade, validated ERP fast, before launch, with little or no legacy team.
Aperigon implements Microsoft Dynamics 365 (Finance & Supply Chain Management) scoped to a launch — finance, order-to-cash, and outsourced supply orchestration — and delivers the validation with it. One audit-ready backbone, standing before your first commercial shipment.
Fixed scope aimed at a launch date, not an open-ended program.
IQ/OQ/PQ and 21 CFR Part 11 documentation, aligned with GAMP 5 Second Edition, delivered with the system, so your first inspection isn't a fire drill.
Commercial supply-chain orchestration, DSCSA serialization, gross-to-net, and revenue recognition as you stand up your own operations.
Most ERP projects hand you a system and leave validation to you or a separate vendor, so it slips past go-live — exactly when you can least afford an inspection finding. Aperigon builds validation into delivery, aligned with GAMP 5 Second Edition, so the system is audit-ready the day you start shipping commercial product.
Fixed, to your launch date.
To your commercial model.
IQ/OQ/PQ, Part 11.
Before first shipment.
Managed services after.
Pre-commercial and newly-commercial biopharma companies — with a product under FDA or EMA review, or recently approved — standing up their own commercial finance, supply chain, and quality operations for a first launch, often alongside contract manufacturing partners.
Staying fully asset-light with no commercial operations of your own? See Asset-Light Life Sciences.
Aperigon pairs Microsoft Dynamics 365 — proven in regulated, GxP environments — with a team that has spent decades delivering validated ERP in Life Sciences, and nothing else. Senior practitioners, backed by a deep Dynamics delivery bench.