Month 2

Dossier Builder

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

AI-structured submission files for FDA 510(k)/PMA, EMA Technical File (MDR Annex II), and ANVISA. Each section includes templates, legal references, and compliance checklists.

Start Free Trial → View Pricing

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

  1. 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.
  2. Auto-Population Your product classification data, literature review outputs, and regulatory profile pre-fill the relevant sections. You review and complete the remaining fields.
  3. 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.
  4. 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 you get

  • 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

Who it is 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

Dossier Builder

Start Free Trial → View Pricing