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Use CaseClinical & Regulatory Submission Automation

AI Agents for Faster, Cleaner Regulatory PackagesAI Agents for Clinical & Regulatory Submission Automation

Alomana agents assemble CTD modules, cross-reference study data, perform regulatory gap analysis and draft submission narratives — compressing timelines from months to weeks while reducing the risk of complete response letters.

About Clinical & Regulatory Submission Automation

Clinical & Regulatory Submission Automation solutions powered by autonomous AI agents enable enterprises to overcome regulatory affairs bottlenecks at scale. Our regulatory submission automation AI platform provides comprehensive automation for intelligent ctd assembly and gap analysis. Trusted by Fortune 500 companies and leading enterprises worldwide for mission-critical clinical & regulatory submission automation operations. Deploy AI-powered agents that work 24/7 to transform your clinical & regulatory submission automation workflows with enterprise-grade security, compliance, and scalability.

Key capabilities include automated document triage and mapping to ctd 2.4, 2.5 and 2.7 sections, cross-referencing engine linking study reports, iss/ise data and labelling claims, regulatory gap analysis against fda, ema and ich guidelines with prioritised findings, ectd-ready output with hyperlinked cross-references and structured metadata. Organizations achieve 50% Faster Submission Assembly, Lower CRL and Day 74 Risk, and Regulatory Affairs Team Leverage through our intelligent automation platform.

Purpose-built autonomous agents, tailored to your stack.

Problem and Solution Overview

The friction today

Regulatory Affairs Bottlenecks at Scale

Assembling NDA, BLA and MAA submissions involves coordinating hundreds of documents, thousands of cross-references and complex quality checks — under strict deadlines with zero tolerance for error.

Common challenges in clinical & regulatory submission automation include high operational costs, slow processing times, manual errors, and scalability limitations. Traditional approaches to clinical & regulatory submission automation struggle with manual ctd assembly across hundreds of clinical, nonclinical and cmc documents, leading to inefficiencies and missed opportunities. Organizations face increasing pressure to modernize clinical & regulatory submission automationoperations while maintaining compliance and reducing costs.

  • Manual CTD assembly across hundreds of clinical, nonclinical and CMC documents
  • Time-consuming cross-referencing between study reports, labelling and prior submissions
  • Regulatory gap analysis relies on specialist knowledge and can miss critical items
  • Version control failures cause submission errors and agency queries
With Alomana agents

Intelligent CTD Assembly and Gap Analysis

AI agents ingest your complete document library, map evidence to CTD sections, identify gaps relative to agency guidelines and generate structured module drafts with full cross-referencing.

Alomana's clinical & regulatory submission automation AI agents provide end-to-end automation with enterprise-grade reliability. Our platform leverages advanced machine learning, natural language processing, and intelligent process automation to deliver 50% Faster Submission Assembly. The solution integrates seamlessly with existing systems including ERPs, CRMs, and legacy applications. Real-time monitoring, audit trails, and compliance reporting ensure governance and transparency. Scalable architecture supports growing workloads without performance degradation.

  • Automated document triage and mapping to CTD 2.4, 2.5 and 2.7 sections
  • Cross-referencing engine linking study reports, ISS/ISE data and labelling claims
  • Regulatory gap analysis against FDA, EMA and ICH guidelines with prioritised findings
  • eCTD-ready output with hyperlinked cross-references and structured metadata

See it in motion

See the agents working on your behalf

Watch how autonomous agents orchestrate data extraction, reasoning and reporting on complex, real-world workloads.

Turn your proprietary data into value

Autonomously analyzes databases, discovers anomalies, and extracts insights from your data

Jade is an autonomous AI data analysis agent that discovers anomalies, generates predictive insights, and automates database analysis across your enterprise systems. Key features include fraud detection, automated reporting, real-time data monitoring, and advanced analytics for business intelligence.
$1M Fraud Prevented

in the last 12 months for one of the largest global servicers across $5B+ in transactions processed.

Data Upload

Upload and process your data files

Drop your files here, or browse

Supports Excel (.xlsx, .xls) and CSV files

Outcomes

What teams achieve with this use case

Organizations implementing clinical & regulatory submission automation AI agents achieve significant improvements across key metrics. Benefits include reduced operational costs, faster processing times, improved accuracy, enhanced compliance, and better scalability. Real-world deployments demonstrate measurable ROI within weeks of implementation. Teams report higher productivity, reduced manual work, and ability to focus on strategic initiatives. The platform supports continuous improvement through machine learning and adaptive algorithms. Enterprise customers benefit from dedicated support, custom integrations, and tailored deployment options including on-premises and cloud-based solutions.

01

50% Faster Submission Assembly

Reduce CTD compilation time from 6–9 months to under 3 months by automating document triage, mapping and first-draft generation.

02

Lower CRL and Day 74 Risk

Systematic gap analysis against current agency expectations reduces the chance of complete response letters and major objections.

03

Regulatory Affairs Team Leverage

Free specialist regulatory affairs directors to focus on strategy, health authority interactions and labelling negotiations instead of document compilation.

Questions, answered

Frequently asked questions

Can agents handle both NDA/BLA submissions and EU MAA packages?

Yes. Agents apply market-specific CTD mapping rules for FDA (NDA/BLA), EMA (MAA), Health Canada, PMDA and other ICH regions — generating regionally adapted module content from the same underlying document library.

How do agents maintain version control across submission documents?

Every document version, cross-reference and section mapping is tracked with full audit history. Agents detect version conflicts, flag superseded study reports and ensure the submission package references only approved document versions.

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