Free Assessment

Life Sciences & Pharma

Structured content management for FDA, EMA, and MDR compliance — where content errors affect patient safety and can delay market authorization by months.

in :: lifesci.propagation <component> Δ safety warning · v3.2 Δ propagating IFU SPL CSR MODULE 3 each × 30+ language variants · multi-market · audit-traceable FIG. 01 / lifesci.propagation ONE CHANGE → ALL ARTIFACTS

Labeling & Clinical Documentation

In Life Sciences, content is a regulated asset. We implement component content management systems (CCMS) that enforce data integrity, traceability, and multi-market compliance at the paragraph level.

  • Structured Product Labeling (SPL)

    We convert unstructured design files into FDA-compliant SPL XML. Drug listing data, package inserts, and medication guides are structured once and published to DailyMed, the FDA Electronic Submissions Gateway, and print simultaneously. Every element carries HL7 SPL vocabulary codes.

  • Instructions for Use (IFU)

    IFUs for medical devices must be published in 30+ languages and comply with EU MDR, FDA 21 CFR Part 820, and ISO 13485. We manage translations at the component level — change a safety warning once, and the system flags all 30 language versions for translation update with full traceability.

  • Clinical Study Reports (CSR)

    CSRs are the backbone of regulatory submissions. We structure them so data tables auto-populate from SAS/R datasets, narrative sections follow ICH E3 guidelines, and cross-references resolve automatically. This accelerates the submission-ready timeline from months to weeks.

Regulatory Compliance Infrastructure

Regulatory requirements differ by market (FDA, EMA, PMDA, TGA) and product class. Your content system must enforce compliance rules, not rely on authors to remember them.

  • 21 CFR Part 11 Compliance

    Electronic signatures, audit trails, and access controls that satisfy FDA Part 11 requirements. Every content change is timestamped, attributed to a named individual, and locked into a tamper-evident baseline. No content leaves the system without validated sign-off.

  • UDI & Symbol Management

    Unique Device Identification (UDI) data and ISO 15223 symbols are managed as structured metadata — not embedded images. When the EU MDR changes a symbol requirement, update the central library once and republish thousands of IFUs with the correct symbols overnight.

  • Multi-Market Submissions

    A single content repository serves FDA (eCTD Module 3), EMA (NeeS/eCTD), and regional agencies. Market-specific profiling generates the correct document set for each authority — same source content, different regulatory packaging.

Free Regulatory Content Assessment

Share a sample IFU, SPL, or submission component. We'll analyze structure, identify multi-market profiling opportunities, and map the path to a component-based regulatory content architecture. No commitment required.

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