Batch Release
Infrastructure.
The operating system for pharmaceutical batch release into the EU. Built for Indian generic manufacturers — connecting QPs, labs, logistics, and regulators on one audit-ready platform.
Today's Reality
- ×Documents scattered across email, SharePoint, WhatsApp
- ×Weeks of back-and-forth with QPs, labs, logistics
- ×Manual compilation for every regulatory audit
- ×No single source of truth for batch status
- ×Expensive consultant fees for coordination work
With PharmaFlow
- ✓One platform for documents, workflow, and audit trail
- ✓Automated completeness checks before QP review
- ✓Inspector-ready records generated automatically
- ✓Real-time batch dashboard for all stakeholders
- ✓Integrated logistics, lab, and temperature data
How It Works
From dossier intake to batch release — one automated pipeline
Dossier Intake
Upload your product dossier. Platform validates completeness against EU regulatory checklists automatically.
Logistics & Testing
Platform fetches live quotes from GDP partners. Lab results and cold chain data flow in via integrations.
QP Review
QP cockpit surfaces everything needed for review. Traffic light dashboard, spec comparison, secure e-signature.
EU Market Access
Release certificates generated automatically. Immutable audit trail ready for HPRA inspection.
Document Management
Centralised upload with version control. Automatic completeness checking against regulatory checklists.
Logistics Integration
Live quotes from GDP-certified partners. Price-locked when selected, tracked end-to-end.
Lab Results
Direct integration with GMP testing laboratories. CoAs pulled automatically into batch records.
Temperature Monitoring
Real-time cold chain data from monitoring devices. Excursion alerts and deviation tracking.
QP Dashboard
Unified view for Qualified Person review. Secure electronic signatures for batch certification.
Audit Trail
Immutable, timestamped records. Inspector-ready exports for regulatory audits.
Why Ireland?
Ireland is Europe's pharmaceutical hub — home to 9 of the top 10 global pharma companies. PharmaFlow is built in Dublin, purpose-designed for the India-EU corridor.
- ✓Direct EU market access via HPRA
- ✓English-speaking EU member state
- ✓5.5 hour overlap with India business hours
- ✓Deep pharmaceutical regulatory expertise
Meet the Team
QP expertise meets technology
Asish Saxena
23 years in pharmaceutical manufacturing. Expert in EU GMP compliance and batch certification.
Deepak Bhattacharya
14 years driving quality excellence. Specialist in quality management systems and regulatory compliance.
Sud Sunkaraneni
14 years building technology for regulated industries. Leading PharmaFlow's digital platform.
Ready to Enter the EU Market?
Join our early access program. We're onboarding pilot manufacturers now.
Dublin, Ireland • Regulatory Infrastructure for Pharma