Intelligent Dossier Assembly
Maps clinical, nonclinical, quality, and statistical content to CTD sections — a first-cut dossier your team reviews, not builds.
Trusted by startups and global leaders
The Submission Should Not Be the Part That Lets the Science Down.
Dossier assembly, gap analysis, and multi-agency management — the most time-consuming and error-prone parts of regulatory submission, handled by AI so your team can focus on the decisions that require their expertise.
Gap Analysis & Completeness Review
Completeness review against FDA, EMA, CDSCO, and ICH rules, gaps ranked by severity — so you catch issues before the agency does.
Multi-Agency Submission Management
Per-market dossier versions, per-agency format, parallel Q&A, and updates that propagate across every regional dossier automatically.
Where Regulatory Submissions Go Wrong
Assembling years of research into a dossier that meets format, completeness, and content standards across markets demands a volume, consistency, and precision manual processes cannot reliably meet.
How We Fix ThisWhat Regulatory Submission AI Manages
From dossier assembly through gap analysis, consistency checking, and multi-agency coordination — every part of submission preparation consuming expert time without requiring expert judgement.
What Your Regulatory Affairs Team Works With Every Day
Four purpose-built workspaces for regulatory scientists, submission managers, and affairs leadership — removing document management burden so expert attention goes to the science and strategy that actually require it.
Submission Project Dashboard
All active submission projects in one view — submission deadline, current completion status by module, open gap items, assigned responsibilities, and regulatory agency communication log. Enough information to understand where every active submission stands, what is blocking it, and who owns the resolution — without a status meeting.
Gap Report
A live, ranked list of identified gaps and inconsistencies across your current dossier — severity ratings, required actions, responsible team members, and target resolution dates. The document your team works from when they sit down to finalise a submission. Updated automatically as gaps are resolved and new source content is added.
Consistency Review Report
A systematic flag list of terminology inconsistencies, numerical discrepancies, and broken cross-references across all modules — presented in a format that allows systematic resolution before submission. These are exactly the kinds of errors that slip through manual review and get caught by agency reviewers at significant cost in time and credibility.
Agency Intelligence Library
A continuously updated database of regulatory guidance documents, recent approval precedents, agency question patterns from previous submissions, and emerging regulatory signals. Giving your team the intelligence to anticipate what agencies will look for before the review begins — so the scientific and labelling strategy is informed by what actually drives agency decisions.
Multi-Market Coordination View
All regional dossier versions, agency timelines, question-and-answer cycles, and response deadlines in one coordinated view. When an update needs to propagate across markets, the platform identifies every affected location automatically. No version inconsistencies across markets. No response that contradicts something submitted elsewhere.
Regulatory Submission AI: What the Numbers Mean.
Each figure shows the cost of getting submission quality wrong.
Book a Live DemoMonths
Lost to a single complete response letter for preventable documentation gaps. Catching those gaps before submission is always worth the time.
$100M+
Typical cost of a major-market NDA by submission. Every avoidable delay at this stage is among the most expensive in the entire development program.
100K+
Pages in a typical global CTD submission. Consistent terminology, cross-referencing, and numerical accuracy across that volume requires AI review — manual checking cannot cover it reliably.
5+
Regulatory markets a single product may be submitted to simultaneously — FDA, EMA, CDSCO, Health Canada, TGA — each with different format requirements and review timelines.
eCTD 4.0
Full eCTD submission support including backbone management, leaf validation, and technical submission to FDA ESG, EMA eSubmission, and CDSCO portal — format errors caught before the agency sees them.
0
Version inconsistencies across regional dossiers when an update is propagated. Every affected location identified automatically — no submission contradicts another.
Who This Platform Serves
Built for every organisation preparing, managing, or supporting regulatory submissions — from large pharma pipeline teams to biotech companies filing their first NDA.
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Pharmaceutical Companies with Active Pipeline
Pharmaceutical Companies with Active Pipeline
Multiple submissions across multiple markets simultaneously. AI-powered dossier preparation and gap analysis reduces time per submission and improves quality — without proportional headcount growth as the pipeline expands.
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Biotech Companies at First Regulatory Submission
Biotech Companies at First Regulatory Submission
Your first NDA or MAA is the most consequential document your company will file. AI that ensures completeness, consistency, and format compliance before submission reduces the risk of a preventable delay — when a complete response letter is not just a setback but a potential existential event.
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Contract Regulatory Affairs Organisations
Contract Regulatory Affairs Organisations
Clients measure you on quality and timeline. AI lets your team handle more submissions at higher quality without proportional headcount growth — a direct advantage as clients compare regulatory performance quantitatively.
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Generic and Specialty Pharma Companies in India
Generic and Specialty Pharma Companies in India
FDA ANDAs, EMA generics, and WHO prequalification dossiers have format requirements unfamiliar to teams used to CDSCO workflows. AI that understands each market's requirements reduces preparation burden, query cycles, and the timeline to first approval.
Built Around the Regulatory Standards Agencies Already Require
Works within your existing document management, eClinical, and data governance infrastructure — no parallel systems.
Submission Format
eCTD & Electronic Submission
eCTD 4.0 backbone structure and pre-submission validation.
Regulatory Standards
ICH & Agency Guidelines
Completeness reviewed against current, continuously updated guidance.
Document Management
Document System Integration
Assembles dossiers from existing document and eClinical systems.
Indian Market
CDSCO & Indian Regulatory Support
Indian regulatory support for domestic and international filers.
Literature
Literature & Evidence Management
Literature search, quality assessment, extraction, and synthesis.
Security
Data Security & Confidentiality
Clinical data secured with configurable data-residency options.
Your Science Deserves a Submission That Does It Justice.
Years of research go into a regulatory dossier — the submission should not be what lets it down. Book a 30-minute demo to see the platform handle dossier assembly, gap analysis, and multi-agency requirements.
Book a Regulatory Demo
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Frequently Asked Questions
[ 1 ]
How does the AI understand regulatory requirements across different agencies?
The platform maintains an updated library of regulatory guidance documents, agency-specific requirements, and ICH guidelines. When preparing for a specific market, the relevant requirements are applied to the completeness review and gap analysis. As guidance evolves, the library updates — so your dossier is always assessed against current requirements.
[ 2 ]
Can the platform handle submissions that include proprietary clinical data?
Yes. Data is handled under appropriate security and confidentiality controls. For organisations with data residency requirements — including DPDP Act compliance for Indian companies — the platform can be deployed to keep data within defined geographic boundaries.
[ 3 ]
How much of the regulatory writing does the AI actually do versus what requires a qualified regulatory scientist?
The AI handles structural assembly, gap identification, consistency checking, and first-cut drafts of literature-based sections. Every substantive scientific claim and strategic regulatory decision — benefit-risk, labelling strategy, agency responses — requires qualified regulatory input. The AI removes the document management burden so your team can focus on the science.
[ 4 ]
Does the platform support electronic submission formats including eCTD?
Yes. The platform outputs eCTD 4.0, handles backbone and leaf file management, validates structure before filing, and supports technical submission for FDA ESG, EMA eSubmission, and CDSCO portal.
[ 5 ]
Can this be used for ANDA and generic drug submissions, not just NDAs?
Yes. ANDA preparation is supported including bioequivalence module assembly, product quality formatting, and generic-specific completeness requirements. For Indian companies seeking FDA ANDA approval, the platform handles the format differences between CDSCO workflows and FDA requirements.
[ 6 ]
How does the platform handle updates that need to propagate across multiple regional dossiers?
When an update is made — a labelling amendment, an agency response, an updated clinical summary — the platform identifies every location across every regional dossier where it's relevant and flags it for propagation. The regulatory team approves each change, maintaining full human oversight of every submission version.
Global presence
