The Review Problem No One Talks About

You’ve invested millions in your regulatory infrastructure. You have a publishing system, a document management system, maybe even a RIM platform. But when it comes to the final mile — the moment your team actually needs to review what’s being submitted to the FDA, EMA, or Health Canada — they’re stuck toggling between folder trees, PDF viewers, and spreadsheets.

The irony is brutal: the most critical quality gate in your submission process is the one with the least purpose-built tooling.

If you’re a Senior Director of Regulatory Affairs or Regulatory Operations, you already feel this. You see it in the last-minute scrambles before filing deadlines. You see it in the overtime hours your team logs checking hyperlinks by hand. You see it when a CRO partner emails asking for “just one more export.” And you see it when a technical rejection arrives for something that should have been caught in review.

DnXT Reviewer was built to eliminate all of it.

What a Regulatory Review Platform Should Actually Do

Most organizations review eCTD submissions using tools that were designed for something else — an eCTD viewer bolted onto a publishing suite, or a basic PDF reader with a folder tree. These tools let you open files. They don’t help you understand your submission.

DnXT Reviewer is a purpose-built regulatory review and intelligence platform. It doesn’t just display documents. It gives your team — and your external partners — a structured, AI-enhanced environment to navigate, analyze, annotate, and validate every aspect of a submission before it reaches a health authority.

Here’s what that looks like in practice.

Full Submission Intelligence at a Glance

The moment your team imports a submission, DnXT Reviewer reads the eCTD XML backbone and builds the complete regulatory structure automatically. No manual metadata mapping. No configuration. Your reviewers go from import to active review in seconds.

From the dashboard, your team sees everything that matters:

  • Pending approvals and task assignments so nothing falls through the cracks
  • Application and submission statistics across your entire portfolio
  • Comment and hyperlink status for every active review
  • Recently imported applications for immediate access
  • Intelligence widgets with configurable analytics that surface what needs attention

For a Senior Director managing multiple submissions across regions and therapeutic areas, this is the difference between asking “where are we?” and already knowing.

Navigate the Full Submission Lifecycle — Not Just Files

DnXT Reviewer doesn’t show you a flat list of PDFs. It reconstructs the complete regulatory hierarchy — Module 1 through Module 5, every sequence, every lifecycle event — and lets your team navigate it the way regulators think about it.

Chronology Report

See the complete submission timeline for any application: every sequence, submission type, and filing date, enriched with AI-generated descriptions. Filter by past submissions or planned future filings. Your regulatory operations team gets a single source of truth for “what have we submitted, and what’s coming next.”

Labeling History

Track every labeling document across its full lifecycle — current versus superseded versions, draft versus approved status, SPL document counts. When the FDA asks about your labeling history, your team pulls the answer in seconds, not hours of digging through folder structures.

Clinical Studies Report

Automatically identify and classify every Module 5 clinical study document by study type and phase. For organizations with complex development programs, this transforms how your team tracks what clinical evidence exists across submissions.

Correspondence Tracking

Every communication with a health authority — cover letters, agency responses, meeting requests — organized by direction and type. AI-powered scanning automatically classifies M1 correspondence documents and extracts questions, commitments, and references. No more hunting through email chains or shared drives to find what the agency asked six months ago.

Specification Dashboard

Analyze product specifications with stability trending, batch performance tracking, impurity risk scoring, and analytical method readiness — all extracted from your submission documents. This is regulatory intelligence that most organizations build manually in spreadsheets, delivered automatically.

Hyperlink Validation That Actually Works

Broken hyperlinks remain one of the most common causes of technical rejection. Your team knows this, which is why they spend hours — sometimes days — manually clicking through links before every filing.

DnXT Reviewer validates every hyperlink in your submission automatically. Not a sample. Not a spot check. Every link. The result is an actionable report showing exactly which links pass, which fail, and why — with the ability to accept, reject, and annotate link status directly in the platform.

For a Senior Director, this means you stop hearing “we need two more days for link checking” before every submission deadline.

AI Built Into the Review Workflow

DnXT Reviewer doesn’t treat AI as a marketing checkbox. It’s embedded at every point where your team needs faster understanding:

  • Document Summaries — AI-generated summaries of lengthy regulatory documents so reviewers can triage faster
  • Version Difference Analysis — AI-assisted comparison between document versions, highlighting what actually changed and why it matters
  • AI Suggestions — Context-aware recommendations surfaced during document review
  • Intelligent Search — Full-text search across your entire submission archive with AI-generated answers to natural language queries
  • Report Enrichment — AI-generated descriptions across chronology, labeling, correspondence, and clinical reports
  • Copilot Panel — An integrated AI assistant available throughout the review workflow

This isn’t theoretical. These capabilities run on your actual submission data, inside a validated, 21 CFR Part 11 compliant environment.

Collaboration Without Compromise

Regulatory review is rarely a solo activity. Your internal teams, external CROs, and sometimes even partner companies need to review the same submission — often under tight timelines and strict security requirements.

DnXT Reviewer handles this with:

  • Role-based access control — Granular permissions that map to your organizational structure. Give a CRO reviewer access to exactly the modules they need and nothing more.
  • Document annotations — Highlight, underline, strikethrough, and add text annotations directly on documents. Every annotation is tracked with full audit trail.
  • Comments and threading — Application-level and document-level commenting with status tracking and statistics.
  • Secure cloud access — External partners review in the same platform your internal team uses. No file exports, no email attachments, no version confusion.

The cost argument matters here too. Giving a CRO access to your full RIM suite is expensive and risky. DnXT Reviewer provides a targeted, secure review environment at a fraction of the cost and complexity.

Veeva Vault Integration — No More Download-Review-Upload

If your organization runs on Veeva Vault, DnXT Reviewer connects directly with bi-directional synchronization. Inbound sync pulls documents from Vault into the review environment. Outbound sync pushes review outcomes back. Full sync keeps everything aligned.

The platform includes conflict detection, change tracking, and job management — so your team isn’t manually exporting ZIP files from Vault, reviewing them in a disconnected tool, and then manually updating status back in Vault. That workflow is a data integrity risk your validation team has probably already flagged.

Import Anything, From Anywhere

DnXT Reviewer accepts submissions from multiple sources:

  • Direct repository browsing — Connect to your eDMS or file share and navigate folder hierarchies
  • Local upload — Drag and drop a ZIP file or folder from your desktop
  • Cloud import — Pull directly from cloud storage
  • Chunked upload — Large submission packages upload reliably with real-time progress tracking

The import process reads the eCTD structure automatically, registers the application, and makes the submission reviewable immediately. Your team doesn’t configure anything — they review.

Security and Compliance as Foundation

For a Senior Director, features don’t matter if they can’t survive an audit. DnXT Reviewer is built on:

  • 21 CFR Part 11 compliance — Full audit trails, electronic signatures, and access controls
  • Multi-tenant architecture — Tenant-level data isolation with dedicated encryption
  • Azure cloud hosting — Enterprise-grade infrastructure with 99.9% uptime SLA
  • LDAP integration — Connect to your existing enterprise directory
  • Session security — Configurable timeouts, secure cookies, CSRF protection
  • IQ/OQ/PQ validation packages — Ready for your computer system validation process
  • Immutable audit logs — Every action logged with user, timestamp, and change detail

The Strategic Case for a Dedicated Review Platform

If you’re evaluating whether your team needs a dedicated eCTD review platform versus continuing with whatever viewer came bundled with your publishing suite, consider these questions:

  • How many hours does your team spend on manual hyperlink validation before each submission?
  • How long does it take to pull together a complete labeling history or correspondence summary when an agency asks?
  • How do you give CRO partners access to review submissions without compromising security or budget?
  • Can your current tools tell you the review status across all active submissions from a single screen?
  • When was the last time a technical rejection cost you a cycle — and what was that delay worth in lost revenue?

DnXT Reviewer exists because these questions shouldn’t be hard to answer. Regulatory review is the final quality gate before a health authority sees your work. It deserves a platform built specifically for that purpose — not an afterthought bolted onto something else.

If your team is ready to stop treating review as a manual process and start treating it as a strategic capability, we should talk.