Pharma
Select your use case

Regulatory submissions
done before the deadline.

Ranger structures your technical documentation against FDA and EMA requirements — gap analysis, traceability matrices, and submission-ready packages.

Book a meeting
0%
Time saved in submission prep
vs. manual documentation review
24 hrs
Gap analysis turnaround
Full framework review
0%
Requirements traceability
Every clause linked to evidence
0 gaps
Missed requirements
Post-Ranger submission average
How It Works

From raw document
to submission-ready.

Three steps. Built for Regulatory Submissions.

Step 01

Map Your Regulatory Framework

FDA 21 CFR, ICH guidelines, and site-specific requirements are mapped against your documentation once.

Step 02

Run Automated Gap Analysis

Agents cross-reference every requirement against evidence, surfacing gaps and severity rankings overnight.

Step 03

Generate Submission Package

A complete traceability matrix with evidence links and gap resolution plan, submission-ready.

Product Walkthrough

See Ranger in Action

A concept walkthrough showing how Ranger handles your document workflows

Validation & Compliance
Validation Docs
PDF
IQ-OQ-PQ-Bioreactor-Rev2.pdf
88 pages
PDF
URS-Filling-Line-2026.pdf
42 pages
Regulatory
XLS
21-CFR-Part-11-Checklist.xlsx
134 rows
PDF
FDA-Warning-Letter-Response.pdf
18 pages
Deviations
XLS
Deviation-Log-Q4-2025.xlsx
67 rows
PDF
CAPA-Register-2025.pdf
22 pages
6 files · Validation & Compliance
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The Difference

Same workflow.
Completely different outcome.

What actually changes when a pharma team runs on Ranger.

Before Ranger
20 manual steps
Intake
Receive submission request
Identify applicable regs
Collect source documents
Log in tracker
Assign regulatory lead
Document Review
Read regulatory guidance
Extract requirements
Re-check sections
Cross-reference prior submissions
Identify gaps
Drafting
Draft each section
Link supporting evidence
Internal review
Revisions
Medical / QA review
More revisions
Submission
Compile dossier
Format to CTD structure
Final QA check
Submit to authority
Before Ranger
20 manual steps
Intake
Receive submission request
Identify applicable regs
Collect source documents
Log in tracker
Assign regulatory lead
Document Review
Read regulatory guidance
Extract requirements
Re-check sections
Cross-reference prior submissions
Identify gaps
Drafting
Draft each section
Link supporting evidence
Internal review
Revisions
Medical / QA review
More revisions
Submission
Compile dossier
Format to CTD structure
Final QA check
Submit to authority
After Ranger
10 automated steps
Upload & Context
Upload your documents
Select use case context
Ranger Agents
Parse regulatory guidance
Map requirements to evidence
Flag gaps & missing data
Draft CTD-structured sections
Auto-cite supporting studies
Review & Deliver
Review AI output
Apply expert judgment
Export / submit
50%
fewer steps
Drag to compare
Customer Story
PharmaRegulatory Compliance

“Ranger delivered unprecedented operational excellence across our regulatory workflows.”

D
Director of Regulatory Affairs
Global Pharmaceutical Company
Challenge
Regulatory submissions buried in specialist knowledge — months of manual cross-referencing
Solution
AI agent maps clinical data to regulatory frameworks and auto-generates submission packages
Result
2x case throughput with the same team — first-deployment accuracy at 96.1%
96.1%
First-deployment accuracy
Auto
Confidential exports
2×
Case throughput

FAQ

Common Questions

Energy

Ready to see what
60% faster looks like
for your team?

Book a 30-minute call. We'll walk through the exact workflows built for your operation — your specs, your requirements, your language.

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