A label that clears in the US has to be right
in every other market too.
Labeling compliance is expensive, slow, and surprisingly fragile. Composit accelerates label creation, manages templates across SKUs, and guides every element against every market's requirements — from first draft to print-ready, without the consultants.
Template Management
Templates created rapidly by AI, managed across every SKU. Changes propagate correctly. Versioning and change history maintained automatically.
Regulatory Compliance
Artwork, symbology (ISO 15223), UPC, UDI, and jurisdiction-specific requirements — all applied in context as you author, for every market simultaneously.
Drug Labeling & SPL
Pharmaceutical labels with NDC codes and required elements. Structured Product Labeling (SPL) file generation for FDA drug labeling submissions.
Review & Approval
Collaborative workflow across multiple stakeholders and SKU variants. Full review and approval cycle with version control and audit trail.
From label requirements to print-ready — every market, every SKU.
Label compliance involves far more than text. Artwork specifications, symbology standards, UDI requirements, barcode formats, and jurisdiction-specific content rules all vary by market — and all have to be right before a label goes to the printer. Composit manages all of it, across every SKU in your portfolio, continuously.
Template Creation & Management
AI-generated templates, managed across your full SKU portfolio.
Label templates generated rapidly by AI and managed with full version control across every product variant. Template changes propagate correctly to all affected SKUs. The operational burden of template management — which grows with every new market, indication, or product line — is handled automatically.
Drug Labeling
Pharmaceutical labels with all required elements — including NDC.
Drug labeling has additional complexity beyond device labels — NDC codes, required statement formats, boxed warning requirements, and more. Composit handles pharmaceutical labeling requirements and generates Structured Product Labeling (SPL) files for FDA drug labeling submissions.
Change Control
Every change tracked. Every version auditable.
Cleared indications connected from submission through to label — no drift between what was cleared and what the label says. Change control managed formally so every label update is documented, approved, and traceable. Composit hands off to the printer; everything before that handoff is its responsibility.
Regulatory Requirements by Market
Every market's requirements applied as you author.
21 CFR 801 (US device labeling), EU MDR Annex I, IVDR, ISO 15223 symbology, UDI (FDA and EU), UPC/barcode specifications, and country-specific requirements — displayed in context as you write, so every element is authored against the rules that apply to it. Divergences between markets surfaced automatically.
Collaborative Review & Approval
Multi-stakeholder review across multiple versions and SKUs.
Labels go through multiple versions and multiple stakeholders before approval — regulatory, marketing, legal, quality. Composit manages the full review and approval cycle with version control, comment threading, and a complete audit trail. Every approved version documented and retrievable.
Integrations
Connected to Clarit, Folio, and your existing QMS.
Label requirements and design outputs from Clarit feed directly into Composit. Submission-ready labeling documentation handed off to Folio. Integrates with Clarit natively and with third-party eQMS platforms — Veeva, MasterControl, Greenlight Guru, and others — for companies that already have a QMS in place.