Dossier Builder

From blank page to submission-ready dossier — structured, referenced, compliant.

Regulatory dossiers are complex, multi-hundred-page documents that must follow exact agency formats. Abkus Academic generates the full structure for each submission type — populated with your product data, literature evidence from your reviews, classification results, and compliance checklists. Each section includes the legal references, required content, and templates so your team knows exactly what to write and where.

How it works

Submission Type Selection

Choose your submission: FDA 510(k), FDA PMA, EMA MDR Technical File, EMA IVDR, ANVISA 8-module dossier, or Health Canada MDA. The structure is generated automatically.

Auto-Population

Your product classification data, literature review outputs, and regulatory profile pre-fill the relevant sections. You review and complete the remaining fields.

Compliance Check

Each section includes a compliance checklist against the agency's requirements. Items are marked complete, pending, or missing — with guidance on what to add.

Export & Review

Export any section or the full dossier as structured DOCX or PDF. Each export includes section references, legal citations, and a revision history log.

What's included

✓FDA 510(k): all 17 sections including substantial equivalence summary
✓FDA PMA: all 16 modules with clinical data placeholders
✓EMA MDR Technical File: Annex II + Annex III complete structure
✓EMA Clinical Evaluation Report (CER) template — MDR Article 61
✓ANVISA: 8-module dossier (Módulos I–VIII) per RDC 185/2001 / RDC 751
✓Health Canada MDA application structure
✓Legal references auto-inserted per section (CFR, MDR articles, RDC)
✓Compliance checklist per section — checked against current agency guidance
✓Export to DOCX, PDF, and structured Markdown

Coverage

🇺🇸

FDA submissions

510(k) — 17 sections, indications for use, substantial equivalence
PMA — 16 modules, clinical investigation data
De Novo — classification request structure
IDE application — investigational device sections

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EMA submissions

MDR Technical File — Annex II (complete)
MDR Annex III — EU Declaration of Conformity
IVDR Technical Documentation
Clinical Evaluation Report (CER) — MDR Article 61
EUDAMED UDI/Device registration workflow

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ANVISA submissions

Módulo I — Informações administrativas
Módulo II — Informações do produto
Módulo III — Informações técnicas
Módulos IV–VIII — Pré-clínico, clínico, qualidade, rotulagem, pós-mercado

Who is it for

Regulatory affairs teams building first submissions
CROs managing dossier preparation for multiple clients
Startups without in-house regulatory expertise
University labs preparing for clinical trial applications
Companies expanding from one market to multiple jurisdictions

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