Solutions›Regulatory

Submissions faster. Across every jurisdiction.

AI agents that track regulatory requirements across health authorities, automate dossier preparation, manage labelling changes, and keep your submission pipeline moving.

Talk to our regulatory team
Our perspective

Regulatory teams are the bottleneck nobody talks about.

MULTI-JURISDICTION REGULATORY OPSUS FDAActive83%AIEMAIn review67%AICDSCO IndiaPreparing42%AIPMDA JapanPlanned17%AICSR DraftingeCTD AssemblyReg Intelligence

Every new market means tracking different requirements, assembling different dossier formats, managing different health authority timelines, and coordinating labelling changes. Regulatory teams are stretched across dozens of jurisdictions.

Zelthy gives regulatory teams an intelligence layer. AI agents monitor requirement changes across jurisdictions, flag gaps in dossier readiness, automate document assembly, and keep submission pipelines visible.

The regulatory pipeline

From intelligence to approval. Across every authority.

Regulatory affairs is a pipeline — requirements flow in, submissions flow out. Speed and accuracy at every stage determine market access timelines.

Requirements change constantly. Most teams find out late.

Health authorities update guidelines, publish new requirements, and shift priorities across dozens of jurisdictions. Regulatory teams need to know what's changed, what's coming, and what it means for their portfolio — before it impacts a submission.

Without a platform

Requirement monitoring is manual. Regulatory team members subscribe to authority newsletters. Cross-jurisdiction impact analysis happens in spreadsheets. Changes are discovered when a submission is rejected.

With Zelthy

AI-powered monitoring across health authorities. Automated change detection with portfolio impact analysis. Proactive alerts when requirements change for your active products. Jurisdiction comparison tools for multi-market strategies.

From pipeline chaos to submission velocity

Track everything. Submit faster.

Regulatory engagements start with your submission pipeline: map jurisdiction requirements, deploy tracking and assembly workflows, layer AI intelligence for requirement monitoring, and enable your regulatory team to scale across markets.

Your pipeline. Your jurisdictions. Your bottlenecks.

Every regulatory team has a different bottleneck — some struggle with dossier assembly, others with tracking requirements across jurisdictions, others with health authority query management. Zelthy works with your regulatory affairs team to map the submission pipeline end-to-end: active submissions, jurisdiction-specific requirements, dossier readiness gaps, and labelling change workflows.

Outcome

Complete submission pipeline map with jurisdiction requirements and gap analysis

Timeline
1–2 weeks
40%
faster submissions
8
health authorities tracked
100%
dossier gap visibility
4-8 wks
to deployment
Proof

Proven across jurisdictions.

Regulatory · Multi-jurisdictionAsia-Pacific
Read the full story →

A top-10 pharma company's regulatory team was managing submissions across 8 health authorities using email, shared drives, and manual trackers — with no single view of pipeline status.

40% faster submissions8 authorities trackedAutomated gap analysisZero missed deadlines
Use Cases

Everything we can deploy for Regulatory.

Submission Pipeline Management
Unified view of all submissions — tracking, milestones, health authority query coordination.
Dossier Assembly & eCTD
Document organization, publishing validation, multi-stakeholder review, submission packages.
Regulatory Intelligence
Monitoring guidelines, requirement changes, precedent decisions, and portfolio impact.
Clinical Study Report Drafting
AI-assisted CSR — section drafting, quality review per ICH E3, cross-reference validation.
Labelling Management
Core data sheet, local adaptation, artwork coordination, change impact analysis.
Variation & Change Management
Post-approval variation classification, submission prep, cross-jurisdiction tracking.
Explore use cases across all verticals

Ready to accelerate regulatory timelines?

Talk to our regulatory team. We'll show you how AI agents track requirements and assemble dossiers while your team focuses on strategy.

Talk to our regulatory team