Four markets. Channel-specific validation. One workflow.
Each regulatory channel has its own template, rulepack, and strictness profile. DossierDock loads the right validation logic for the channel you select, so your team works within one consistent workflow while meeting channel-specific requirements.
AMCP Format 5.0
Production-quality end-to-end. Pilot-ready.
Regulatory context
AMCP Format 5.0 is guidance-aligned, not a regulatory mandate. Payer and PBM intake requirements vary. DossierDock separates AMCP guidance linting (advisory by default) from payer-specific intake mechanics (modeled via overlays and channel profiles).
What DossierDock validates
Required section completeness across all AMCP sections, with N/A policy enforcement for dossier types A/B/C. Artifact openability and format checks. Password-protected PDF detection. Filename linting (advisory). L1 consistency: cutoff date, primary endpoint name, and sample size cross-section agreement. Table schema validation (configurable).
What DossierDock exports
Standard ZIP with manifest, HTML index, preflight report, and traceability matrix.
EU HTA JCA
L0 structural validation is production-quality. PICO scope UI is implemented. Active development on PICO/REA structuring depth for full pilot readiness.
Regulatory context
The EU Joint Clinical Assessment framework has a clear normative hierarchy. Annex I of Implementing Regulation (EU) 2024/1381 contains binding "shall" requirements. Annex 2 Technical Specifications and Guidance are non-binding. Their "should" conventions are advisory unless tightened by an org overlay.
What DossierDock validates
Annex I structural requirements (blocking by default). Annex 2 hygiene checks: password-protected files, D.1 full texts as PDF, RIS reference list presence, watermark and PDF usability conventions (warning by default). Appendix D bucket taxonomy (D.1–D.9) as metadata-first categories. PICO scope registry with evidence linkage. Amendment bundle packaging (minimal hard-gates plus advisory). EU HTA IT platform constraints modeled as environment-specific profiles with provenance.
What DossierDock exports
Template-compliant package. Folder-tree vs. metadata approach tracked per platform evidence.
Germany AMNOG / G-BA
Rulepack and export layout implemented. Trial-upload evidence pack (live portal validation) is in progress to confirm edge behaviors before claiming full portal certification.
Regulatory context
Germany's G-BA portal enforces strict technical gates at upload. ZIP must contain Modul1–Modul5 at root (no wrapper directory). Per-file size limits, total size limits, path-length caps, and restricted characters are enforced by the portal.
What DossierDock validates
Portal gate enforcement: ZIP root structure, size limits, path-length caps, invalid character detection. Dossier structure checks per Anlage II.1: module structure, RIS placement, required PDFs, ASCII program-code validation. Portal-aligned export layout (Modul1–Modul5 at ZIP root, no wrapper).
What DossierDock exports
Portal-aligned ZIP matching current documented G-BA portal rules.
CDA-AMC
Core channel constraints validated. Additional portal mechanics are tenant-specific and demand-driven.
Regulatory context
CDA-AMC reimbursement review submissions use a SharePoint channel with specific packaging constraints. CDA-AMC encompasses multiple template families across review phases. DossierDock models the submission channel constraints that are consistent across them.
What DossierDock validates
Decoded path length ≤ 400 characters. ZIP packaging enforcement. Multi-ZIP naming convention guidance. Filing window and access lead-time awareness.
What DossierDock exports
ZIP with SharePoint-compatible path constraints.