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Intelligent Document Processing for Pharma
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 brief
Start with what is not working.
Good software decisions begin with the constraint, not a list of features or a preferred technology.
01
Document versions for your CTD dossier scattered across shared drives with no clear audit trail of what changed and who approved it?
02
Regulatory affairs spending weeks manually assembling submission packages that a properly structured system could generate in hours?
Plain answer
Intelligent document processing for pharma structures, validates, and compiles regulatory submission documents automatically: CTD module hierarchy, eCTD XML generation validated against FDA, EMA, and PMDA specifications, and electronic signature workflows with a tamper-evident audit trail. RaftLabs builds this for pharmaceutical regulatory affairs teams that need structured document control and multi-market submission tracking, without the cost and configuration overhead of enterprise vault platforms.
What to remember
- 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.
Proof
- 100+
- software products shipped since 2015
- RaftLabs delivery record
- 4.9/5
- average client rating across delivered projects
- Clutch, verified reviews
- Fixed price
- scope and cost agreed in writing before any development starts
- Every RaftLabs engagement
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.
That system is intelligent document processing applied to regulatory submissions: structured intake, automated validation against agency specifications, and compiled, audit-ready output, not a shared drive with tighter permissions.
Capabilities
What we build
- 01CTD-structured document management
Repositories mirroring the five-module CTD hierarchy with mandatory-section flagging and maintained cross-module document links.
- 02Version 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.
- 03Submission format checks
Automated validation against each agency's technical requirements, surfacing errors at the document level before assembly.
- Built with
- FDA · EMA · PMDA
- 04eCTD compilation and validation
XML backbone generation with correct leaf numbering and section codes, validated against the agency DTD before the package leaves the system.
- 05Electronic 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
- 06Multi-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
- Week 101
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.
- Weeks 2-402
CTD structure and workflow design
Module hierarchy, approval sequences, and eCTD compilation logic designed against your specific agencies and process.
- Weeks 5-1103
Build and integrate
Document repository, version control, and eCTD validation built in parallel, tested against real submission scenarios.
- Final 2-3 weeks04
Launch and team training
Regulatory affairs teams trained on the new workflow before full rollout.
Why us
Why regulatory affairs teams choose RaftLabs
- 01Senior 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.
- 02Fixed price before development starts
We scope the work, calculate the cost, and lock it in writing before any development starts.
- 03Shipping production software since 2015
Real engagements across SaaS, fintech, healthcare, and logistics, not every one published as a named case study. Track record building regulated healthcare platforms.
- 04We'll tell you honestly when Veeva Vault fits better
Custom is right below a certain submission volume, not a default recommendation.
- 05Validation controls built to the standard, not bolted on
21 CFR Part 11 documentation and test evidence support your IQ/OQ/PQ process.
What clients say
What our clients say
Three-year average engagement. Founders and operators describing the work in their own words. No marketing varnish.
Nuala C.
IrelandDirector, BrandFire
RaftLabs was outstanding at addressing our complex platform needs, delivering a stable, high-performance loyalty application that has been genuinely loved by the customers.
Proof
Case studies
Useful next steps
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Read moreFrequently 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
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.
- 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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