Intelligent Dossier Assembly
Maps clinical, quality, and statistical content to CTD sections for review, not assembly.
Award-Winning Regulatory Submission AI
The Submission Should Not Be the Part That Lets the Science Down.
AI handles dossier assembly, gap analysis, and multi-agency filing, so experts decide, not compile.
Gap Analysis & Completeness Review
Completeness checked against FDA, EMA, CDSCO, and ICH rules, with gaps ranked by severity.
Multi-Agency Submission Management
Per-market dossier versions and parallel agency Q&A, with updates propagated 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
Every part of submission prep that eats expert time.
What Your Regulatory Affairs Team Works With Every Day
Purpose-built workspaces that take the document burden off your regulatory team.
Submission Project Dashboard
Every active submission in one view: deadlines, module status, open gaps, and owners.
Gap Report
A live, severity-ranked list of dossier gaps with actions, owners, and due dates.
Consistency Review Report
Terminology, numerical, and cross-reference errors flagged across modules before filing.
Agency Intelligence Library
Current guidance, approval precedents, and agency question patterns in one library.
Multi-Market Coordination View
All regional dossiers, timelines, and Q&A cycles coordinated, with updates auto-propagated.
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 team filing regulatory submissions.
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Pharmaceutical Companies with Active Pipeline
Pharmaceutical Companies with Active Pipeline
Multiple submissions, multiple markets, same team.
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Biotech Companies at First Regulatory Submission
Biotech Companies at First Regulatory Submission
First NDA or MAA, checked before it is filed.
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Contract Regulatory Affairs Organisations
Contract Regulatory Affairs Organisations
More client submissions without added headcount.
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Generic and Specialty Pharma Companies in India
Generic and Specialty Pharma Companies in India
FDA ANDA, EMA generic, and WHO formats handled.
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
Award-Winning AI Development & Consulting
100 Fastest Growth Companies
Global Spring Winner
Top App Development Company
AWS Partner Network
Google Cloud Partner
Highly Rated on Trustpilot
Verified Agency
Top App Development Company
ASSOCHAM Member
Frequently Asked Questions
[ 1 ]
How does the AI understand regulatory requirements across different agencies?
A live library of FDA, EMA, CDSCO, and ICH guidance drives every completeness review and gap analysis.
[ 2 ]
Can the platform handle submissions that include proprietary clinical data?
Yes. Clinical data stays under strict confidentiality controls, with data-residency and DPDP Act deployment options.
[ 3 ]
How much of the regulatory writing does the AI actually do versus what requires a qualified regulatory scientist?
AI does assembly, gap checks, and first drafts. Scientific claims and strategy stay with your regulatory scientists.
[ 4 ]
Does the platform support electronic submission formats including eCTD?
Yes. eCTD 4.0 output with pre-filing validation and filing to FDA ESG, EMA eSubmission, and CDSCO portal.
[ 5 ]
Can this be used for ANDA and generic drug submissions, not just NDAs?
Yes. ANDA support covers bioequivalence modules, product quality formatting, and CDSCO-to-FDA format differences.
[ 6 ]
How does the platform handle updates that need to propagate across multiple regional dossiers?
Every affected location across regional dossiers is flagged automatically; your team approves each change.
Global presence
