AI dossier preparation and gap analysis for pharma, biotech, CROs, and Regulatory Affairs teams. Complete, consistent submissions — assembled faster, every gap caught before the agency does.
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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.
Maps clinical study reports, nonclinical summaries, quality content, and statistical outputs to the correct CTD sections automatically. Produces a structurally complete, formatted first-cut dossier your team reviews — not builds.
Systematic completeness review against FDA, EMA, CDSCO, and ICH requirements. Every gap ranked by severity, every missing item assigned with a clear description — so your team finds issues before the agency does.
Separate dossier versions per market with format requirements tracked per agency. Q&A workflows managed in parallel. When an update is needed, every affected location across every regional dossier is identified automatically — no missed propagations.
The science behind a submission represents years of research and hundreds of millions in investment. Assembling it into a dossier that meets the format, completeness, and content standards of regulators across multiple markets is a challenge of volume, consistency, and precision that manual processes cannot reliably meet.
See How We Fix ThisFrom dossier assembly through gap analysis, consistency checking, and multi-agency coordination — every part of submission preparation consuming expert time without requiring expert judgement.
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.
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.
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.
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.
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.
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.
Each figure represents a real consequence of submission quality — the cost of getting it wrong, and the value of getting it right the first time.
Book a Regulatory AI DemoBuilt for every organisation preparing, managing, or supporting regulatory submissions — from large pharma pipeline teams to biotech companies filing their first NDA.
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.
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.
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.
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.
Regulatory Submission AI works within your existing document management, eClinical, and data governance infrastructure — no parallel systems, no disruption to active submission workflows.
eCTD 4.0 support including backbone structure, leaf file management, and pre-submission validation for major agency portals.
Completeness review assessed against current guidance, updated continuously as agency requirements evolve.
Assembles dossiers from your existing document management and eClinical platforms — no migration to a new system required.
Indian regulatory support for domestic companies filing internationally and international companies seeking Indian market approval.
Systematic literature search, quality assessment, evidence extraction, and synthesis — connected to major literature databases and citation management tools.
Proprietary clinical data handled under appropriate security controls. Data residency configurations available for DPDP and other geographic data requirements.
Years of research go into the data behind a regulatory dossier. The submission itself should not be the part that lets it down — delayed by avoidable gaps, inconsistent terminology, or format errors a systematic review would have caught. Book a 30-minute demo to see the platform handle your dossier, gap analysis, and multi-agency requirements.
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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.
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.
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.
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.
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.
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.
