Prevent Quality Failures Before They Happen
Qualify Pharmaceutical Sites Faster. With Fewer Gaps. With FDA Readiness Built In.
Regller automates site qualification, equipment validation, and template-based documentation — faster plant commissioning, reducing risk, and improving inspection readiness.
Capacity Expansion Slowed by Manual Qualification
When pharma companies expand manufacturing capacity, the bottleneck is not construction. It is documentation, validation, and regulatory alignment.
- Site Master Plans built manually
- Equipment IQ/OQ/PQ scattered across spreadsheets
- Inconsistent documentation templates
- Review cycles taking months
- Rework during inspections
- ANDA delays due to incomplete validation evidence
The result: Lost revenue. Delayed launches. Increased inspection risk.
Regller Solution: Digital Site Qualification
Regller transforms site qualification into a structured digital workflow built on FDA and global regulatory expectations.
Core Capabilities:
- Structured Site Hierarchy — Organization to Site to Building to Area to Room to Equipment
- Equipment Qualification — IQ/OQ/PQ template-driven generation with auto-populated metadata
- Validation Lifecycle — Draft to Review to Approval to Execution to Close
- Risk-Based Qualification — Integrated risk scoring, CFR-linked compliance checks
- Real-Time Dashboards — Completion %, open deviations, documentation readiness
Who Is This For?
Designed for Growing Pharma and CDMOs
- CDMOs expanding US manufacturing
- Generics manufacturers preparing ANDA
- Biotech scaling to commercial production
- Sites recovering from FDA 483 observations
- Companies modernizing paper-based validation
From Construction to FDA Readiness
Construction
↓ Asset Registration
↓ Risk Assessment
↓ IQ/OQ/PQ Generation
↓ Review and Approval
↓ Inspection-Ready Documentation
Why Regller Is Different
Not just document storage. A regulatory intelligence platform.
Most systems store documents. Regller goes further:
- Builds documents using regulatory-aligned templates
- Connects equipment to risk and CFR codes
- Tracks review and approval workflow
- Flags compliance gaps automatically
- Prepares validation evidence for ANDA submission
Value Creation
Up to 50%
Reduction in qualification cycle time
Improved
Inspection readiness score
Reduced
Documentation rework
Faster
ANDA submission preparation
Clear visibility of validation status across sites
Start Qualifying Faster
Transform site qualification from manual bottleneck to digital advantage.