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📋 RegIntel Powered by NOVA

"Your complete regulatory dossier — in weeks, not months."

RegIntel reads your clinical study reports, product quality data, and nonclinical packages — identifies gaps against CDSCO, FDA, or EMA requirements — and compiles the complete regulatory dossier in the correct authority-specific format. Your regulatory affairs team reviews and submits. Not rebuilds.

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Agent Details
Powered byNOVA
IndustryPharma · Life Sciences
Output typeFull dossier compilation
AuthoritiesCDSCO · FDA · EMA
FormateCTD v4.0 · Common Dossier
Data isolation✓ 6 layers
Audit trail✓ Immutable

RegIntel delivers a complete, submission-ready dossier. Your team reviews, approves, and submits — not rebuilds from scratch.

Supported Regulatory Authorities

Six authorities. One agent. Zero rebuilding.

RegIntel knows the exact dossier structure, section requirements, and submission format each authority expects. Switch authority — the format changes automatically.

🇺🇸
FDA
Food and Drug Administration · United States
What RegIntel compiles
  • ✓NDA / ANDA / BLA submission package
  • ✓Modules 2–5 CTD summaries (ICH format)
  • ✓IND application and protocol dossier
  • ✓PDUFA section 505(b)(1) and (b)(2)
  • ✓CMC — Chemistry, Manufacturing & Controls
  • ✓Risk Evaluation and Mitigation Strategy (REMS)
Format
eCTD v4.0ESG compliant21 CFR aligned
🇪🇺
EMA
European Medicines Agency · European Union
What RegIntel compiles
  • ✓Marketing Authorisation Application (MAA)
  • ✓Centralised procedure dossier (EMA/CHMP)
  • ✓Module 1 EU-specific administrative section
  • ✓Risk Management Plan (RMP) per GVP Module V
  • ✓Paediatric Investigation Plan (PIP)
  • ✓Scientific advice and parallel consultation dossier
Format
eCTD v4.0eSubmission GatewayEudraVigilance ready
🇯🇵
PMDA
Pharmaceuticals and Medical Devices Agency · Japan
What RegIntel compiles
  • ✓J-NDA (新医薬品承認申請) dossier compilation
  • ✓Common Technical Document — PMDA Module 1 (Japan-specific)
  • ✓CTD-Q / CTD-S / CTD-E Japanese summaries
  • ✓Clinical data package per MHLW notification
  • ✓Foreign clinical data bridging study documentation
  • ✓GMP conformity assessment documentation
Format
eCTD v4.0PMDA GatewayMHLW aligned
🇮🇳
CDSCO
Central Drugs Standard Control Organisation · India
What RegIntel compiles
  • ✓Form 44 / New Drug Application dossier
  • ✓Module 1 — CDSCO administrative documents
  • ✓Clinical trial application (Phase I–III)
  • ✓Import / manufacturing licence documentation
  • ✓Bioavailability / bioequivalence data package
  • ✓Fixed-dose combination application
Format
CTD formatSUGAM portal readyDrugs Act 1940 aligned
🇦🇺
TGA
Therapeutic Goods Administration · Australia
What RegIntel compiles
  • ✓Australian Registration Dossier (CTD format)
  • ✓Module 1 — TGA-specific administrative data
  • ✓New prescription medicine registration
  • ✓Clinical evaluation report (CER) requirements
  • ✓Risk management plan per TGA guidelines
  • ✓ARTG (Australian Register of Therapeutic Goods) submission
Format
eCTD v4.0TGA eBusiness ServicesTGO aligned
🌍
WHO
World Health Organization · Prequalification Programme
What RegIntel compiles
  • ✓WHO Prequalification (PQ) dossier for medicines
  • ✓WHO-PQ Module 1 — product and applicant information
  • ✓Quality, safety and efficacy documentation (QSE)
  • ✓API and finished pharmaceutical product (FPP) data
  • ✓Site master file and manufacturing documentation
  • ✓Post-prequalification variation dossier
Format
WHO PQ formatINN alignedGMP compliant
How It Works

From raw data to submission-ready dossier.

RegIntel replaces weeks of manual dossier assembly with an automated workflow that reads, gaps-analyses, and compiles — in the exact format each authority expects.

01
Ingest your source documents

RegIntel reads clinical study reports (CSRs), nonclinical study summaries, product quality data, and any existing regulatory correspondence. Supports PDF, Word, structured data files.

02
Gap analysis against authority requirements

NOVA cross-references your documents against the exact requirements of the selected authority — CDSCO, FDA, or EMA — and produces a gap report identifying missing data, insufficient evidence, and formatting issues.

03
Compile the dossier in correct format

RegIntel assembles Modules 2–5 CTD summaries, the authority-specific Module 1, and all supporting documents — structured in eCTD v4.0 format or the authority's required submission structure.

04
Your team reviews and submits

The complete dossier is delivered to your regulatory affairs team for review. Every section is source-traced — your team knows exactly where each claim came from. Submit when ready.

Key Capabilities

What makes RegIntel different.

🧠
Authority-specific intelligence

NOVA is trained on each authority's actual submission guidelines — not just publicly available guidance. RegIntel knows what CDSCO assessors flag, what FDA reviewers look for, and what EMA CHMP expects.

📋
Full source traceability

Every section of the compiled dossier is source-traced to the original document and page. Your regulatory team can verify any claim in seconds — no more hunting across hundreds of files.

🔄
Multi-authority in one workflow

Run parallel submissions to CDSCO, FDA, and EMA from the same source data. RegIntel adapts the format, Module 1 content, and administrative sections for each authority automatically.

⚡
Weeks, not months

Manual dossier compilation for a single authority typically takes 2–4 months for a mid-size regulatory team. RegIntel compresses this to days for the first draft, with subsequent iterations in hours.

🔒
Sponsor data isolation

Your dossier data never reaches another sponsor. Six architectural isolation layers ensure your clinical data, product information, and regulatory strategy cannot be accessed by any other organisation.

📊
Immutable audit trail

Every document read, every gap identified, every section generated is logged with a timestamp and user record. Your regulatory submission process has a complete, audit-ready history from day one.