Pharma Regulatory Document Management Software

The cost of managing regulatory documents in shared drives

A full NDA or MAA dossier spans hundreds of documents across five CTD modules, each with mandatory sections that vary by agency and submission type. Managing that volume in shared drives creates version control problems that don't surface until the submission deadline is approaching. A one-month delay to an NDA submission represents one month of delayed market exclusivity. The root cause is rarely scientific, it's a document management problem: documents aren't ready, approval signatures can't be located, or the electronic package fails agency validation because formatting was applied inconsistently across modules assembled by different team members.

  • CTD module hierarchy with mandatory and optional section tracking by submission type

  • Version control and electronic approval workflows with full audit trail

  • eCTD compilation and validation against FDA, EMA, and PMDA specifications

  • Multi-market submission status tracking across regulatory agencies simultaneously

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The problem

Sound familiar?

  • Document versions for your CTD dossier scattered across shared drives with no clear audit trail of what changed and who approved it?

  • Regulatory affairs spending weeks manually assembling submission packages that a properly structured system could generate in hours?

Short answer

Pharma regulatory document management software organises submission dossiers in CTD module structure, enforces version control with electronic approval workflows, and compiles eCTD packages validated against FDA, EMA, and PMDA requirements. RaftLabs builds custom regulatory document management platforms for pharmaceutical regulatory affairs teams that need structured document control, multi-market submission tracking, and 21 CFR Part 11 compliant electronic signatures, without the cost and configuration overhead of enterprise vault platforms.

Key takeaways

  • CTD-structured repositories flag mandatory sections by submission type and agency, making dossier completeness a system property rather than a manual spreadsheet check.
  • Automated eCTD compilation generates and validates the XML backbone against the agency's DTD before the package leaves the system, catching errors that would otherwise cause a refusal to file.
  • Electronic signatures satisfy 21 CFR Part 11 Sections 11.50 and 11.70, binding each approval to an authenticated identity with tamper-evident audit logging.
  • A platform for a mid-size regulatory affairs team runs $35,000-$65,000, typically delivering CTD management, version control, and multi-market tracking in 10-14 weeks.

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Regulatory document management delivery, by the numbers

compliant electronic document management
21 CFR Part 11
week delivery for regulatory document platforms
10-14
software products shipped
100+
cost delivery
Fixed

The cost of managing regulatory documents in shared drives

A mid-size biotech or specialty pharma company managing five to fifteen active submissions across two or three markets doesn't need an enterprise vault platform. They need a system built around their specific submission types, their specific agencies, and their existing approval process.

Capabilities

What we build

  • 01
    CTD-structured document management

    Repositories mirroring the five-module CTD hierarchy with mandatory-section flagging and maintained cross-module document links.

  • 02
    Version control and approval workflows

    Every revision creates a versioned record with a diff, and documents can't reach submission-ready status without completing the defined approval sequence.

  • 03
    Submission format checks

    Automated validation against each agency's technical requirements, surfacing errors at the document level before assembly.

    Built with
    FDA · EMA · PMDA
  • 04
    eCTD compilation and validation

    XML backbone generation with correct leaf numbering and section codes, validated against the agency DTD before the package leaves the system.

  • 05
    Electronic signatures and audit trail

    Authenticated, tamper-evident signatures with a separately stored, unmodifiable audit trail of every action on every document.

    Built with
    21 CFR Part 11
  • 06
    Multi-market submission tracking

    Consolidated dashboard across all active dossiers, with shared-document revisions flagged across every affected market.

How we work

From scope to live document platform

  1. Week 1
    01

    Submission pipeline scoping

    We map your submission pipeline, the agencies you file with, and how document management works today. You leave week 1 with a written scope document and a fixed-price quote.

  2. Weeks 2-4
    02

    CTD structure and workflow design

    Module hierarchy, approval sequences, and eCTD compilation logic designed against your specific agencies and process.

  3. Weeks 5-11
    03

    Build and integrate

    Document repository, version control, and eCTD validation built in parallel, tested against real submission scenarios.

  4. Final 2-3 weeks
    04

    Launch and team training

    Regulatory affairs teams trained on the new workflow before full rollout.

Why us

Why regulatory affairs teams choose RaftLabs

  • 01
    Senior engineers build what they scope

    The engineers who assess your submission pipeline also build the solution. No bait-and-switch, no offshore handoff after the contract is signed.

  • 02
    Fixed price before development starts

    We scope the work, calculate the cost, and lock it in writing before any development starts.

  • 03
    9 years and 100+ products shipped

    Clients include Vodafone, T-Mobile, Aldi, Nike, Cisco, and Lockheed Martin. Track record building regulated healthcare platforms.

  • 04
    We'll tell you honestly when Veeva Vault fits better

    Custom is right below a certain submission volume, not a default recommendation.

  • 05
    Validation controls built to the standard, not bolted on

    21 CFR Part 11 documentation and test evidence support your IQ/OQ/PQ process.

Have a regulatory document management project?

Tell us your submission pipeline, the agencies you file with, and how document management works today. We'll tell you what we'd build and how.

Talk about your regulatory document management project

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Frequently asked questions

Vault suits large pharma with IT resources to configure and maintain it and submission volumes that justify the licensing cost. For a mid-size biotech or specialty pharma managing five to fifteen active submissions across two or three markets, a custom system built around their submission types and process is typically faster to deploy and less expensive over a three-to-five-year horizon.

The system maintains a separate dossier instance per agency, structured to that agency's requirements, with shared documents linked rather than duplicated so a revision flags across all relevant dossiers simultaneously. A consolidated dashboard shows status across all active dossiers.

Yes. Signatures are bound to a specific authenticated user identity, record the meaning of the signing action, and are linked to the record in a tamper-evident way, satisfying Section 11.50 and 11.70 requirements, with a separately stored, unmodifiable audit trail.

A custom platform typically runs $35,000 to $65,000 depending on the number of agencies you file with, approval workflow complexity, and whether eCTD compilation is built in. A platform covering CTD document management, version control, and multi-market tracking for FDA and EMA is typically deliverable in ten to fourteen weeks.

Work with us

Tell us what you need. We'll tell you what it would take.

We scope Regulatory Document Management Software for Pharma in 30 minutes. You walk away with a clear cost, timeline, and approach. No commitment required.

  • Scope and cost agreed before work starts. No surprises. No obligation.
  • Working prototype within 3 weeks of kickoff.
  • Pay by milestone. You see progress before each invoice.
  • 60-day post-launch warranty. Bug fixes, UI tweaks, and deployment support. No retainer.
  • All conversations are NDA-protected.

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