INDIA TO EU GENERICS
MARKET ENTRY, COORDINATED ACROSS THE PATHWAY
QP led quality release workflow and regulatory coordination, with GDP logistics and GMP testing executed by appropriately licensed partners. PharmaFlow provides one process, one coordinated plan, and one audit trail from dossier intake through batch release.
PharmaFlow is regulatory infrastructure for India to EU generics market entry. We provide the digital rails, integrations, and audit trail that coordinate MAH, QP release, GDP logistics, and GMP testing partners into one traceable process.
2026 focus: 2 pilot LOIs, dossier intake, and MIA submission; execution runs under partner authorization frameworks until our own authorizations are in place.
This page is an investor/operator explainer. It describes how PharmaFlow coordinates India-to-EU generics entry with clear role separation, auditability, and partner-executed regulated activities.
Next step: Reply to the email thread for data room access + a short call.
Next 90 Days (Proof Points)
- •Sign 2 Pilot LOIs (non-binding)
- •Receive MVP dossier packs within 10 business days (SLA) for pilot candidates
- •Submit MIA application for EU entity
- •Lock initial GDP logistics + GMP testing partners for first pilots
Business Model (Early)
Pilot feasibility sprint → ongoing coordination + compliance workspace. Revenue initially from pilot programs and recurring fees per active pathway/batch program (structure may vary by partner and market).
Explicit Scope Limits (Today)
- •We do not claim to hold all authorizations today
- •Regulated execution is performed by appropriately licensed entities
- •PharmaFlow provides the workflow, audit trail, and coordination owner across partners
What We're Raising For (Next 12 Months)
- •MIA submission and QMS buildout
- •Pilot execution under partner authorizations
- •PV partner selection and MAH readiness (optional)
- •Compliance workspace productization (dossier, handoffs, deviations/CAPA, exportable audit packs)
Key Risks and How We Mitigate Them
- •Authorization timing risk: run pilots under partner frameworks while MIA proceeds
- •Dossier quality risk: MVP dossier pack gate + feasibility sprint
- •Partner dependency risk: 2+ vendors per leg + evidence captured into audit packs
- •PV/MAH risk: PV partner in place before acting as MAH
Fragmented Entry
EU entry is fragmented across RA, quality release, logistics, testing, and document control. Small manufacturers get crushed by coordination.
Growing Corridor
The new India-EU corridor increases the incentive to export, but compliance complexity is the bottleneck.
Control Layer
PharmaFlow is the control layer: unify partners and paperwork into a single coordination system.
Operating Model (2026)
Regulatory + Quality
Regulatory coordination + quality release workflows. 2 QPs on the founding team.
Logistics + Testing
GDP logistics (e.g., DHL and WDA 3PLs) and GMP testing labs.
System of Record
Dossiers, handoffs, deviations, batch release workflow, and exportable audit packs.
Licensing roadmap: Until our own authorizations are in place, regulated execution is performed by appropriately licensed partners, coordinated under a single PharmaFlow controlled workflow and audit trail.
MAH scope (optional): For manufacturers that lack an EU Marketing Authorisation Holder (MAH), PharmaFlow can act as MAH for selected products once the appropriate authorizations, QMS, and pharmacovigilance (PV) arrangements are in place and subject to scope by product and market. When a manufacturer already has an MAH, we coordinate with the existing MAH and operate the same end-to-end quality and execution workflow.
Coordination Map (Who Does What)
| Step | Phase | PharmaFlow (In-House) | PharmaFlow Tech | Licensed Partners | Manufacturer |
|---|---|---|---|---|---|
1 | Feasibility | Run feasibility sprint, define target EU path, identify dossier gaps | Checklist, doc requests, timeline + risk register | Input as needed (regulatory, lab, GDP) | Provide product overview + site basics |
2 | Regulatory | Own RA plan and coordinate submissions with the appropriate MAH/authorized entities (PharmaFlow as MAH where applicable, once PV/QMS arrangements are in place) | Submission workspace, version control, approvals, audit trail | Execute/advise where required by jurisdiction and authorization scope | Provide source docs, respond to queries |
3 | Doc Control | Define required docs per batch and per pathway | System of record, templates, immutable audit trail | Contribute execution evidence (temperature logs, storage records, test results, chain of custody) | Upload dossier items + batch docs |
4 | Testing | Define test plan, review outcomes, manage deviations | Test requests, results ingestion, deviation tracking | GMP testing labs perform testing | Provide samples and mfg details |
5 | Logistics | Define shipment requirements + acceptance criteria | Shipment record, temperature data ingestion, exception handling | GDP providers & WDA 3PLs execute transport | Coordinate dispatch readiness |
6 | Importation | Coordinate import steps and compliance via appropriately licensed partners, until our own authorizations are in place | Import checklist, partner handoffs, audit trail | Importer of record (until MIA/WDA is obtained) | Provide required export/import docs |
7 | QP Release | In-house QP-led batch release decision workflow | Release checklist, sign-offs, deviation linkage | Execution under the appropriate licensed authorization framework (partner held, until our own authorizations are in place) | Provide batch docs + respond |
8 | Compliance | Operate ongoing process and partner management | Doc retention, change control, incident log | Provide ongoing execution evidence (storage records, temp logs, test results) as required | Notify changes, provide updates |
The Old Way: Fragmented Vendors
- ×Pay 4-5 separate consultants for RA, QP, import, logistics, and compliance
- ×Manual paper-based batch reviews and QP sign-offs
- ×Information silos between vendors causing launch delays
- ×Limited visibility into temperature excursions and shipment status
- ×Finger-pointing when things go wrong — no single owner
The PharmaFlow Way: One Platform
- ✓Single workflow and audit trail across the 8 steps
- ✓Automated batch review workflows and digital QP sign-off workflow
- ✓Unified data layer — no handoff delays or lost documents
- ✓Temperature data captured from logistics partners, with excursion alerting where instrumentation supports it
- ✓One coordination owner for the full journey
Pilot LOI + Dossier Access
We prioritize pilot slots for manufacturers who can share a minimum viable dossier pack quickly. If you can't share these docs, we're probably not the right partner yet.
Minimum Viable Dossier Pack
10 Business DaysProduct Overview
Name, dosage form/strength, intended EU markets, any prior registrations.
Manufacturing Site Basics
Site name/address + GMP certificate (or last inspection summary).
Quality Snapshot
1 recent batch CoA (or CoA template) + specs + a 1-page stability summary.
Labeling Drafts
Current carton/label + PIL if available (India labeling is fine as a starting point).
Single Owner + Secure Link
Named QA/RA point of contact + data room / folder link.
Note: This is intentionally lightweight. Full CTD modules and validation packs come later, after feasibility.
Founding Team
PharmaFlow is operator led. Execution depends on QP credibility, RA depth, and the ability to run regulated processes.
Asish Saxena
23 years in pharmaceutical manufacturing. Expert in EU GMP compliance and batch certification.
QP release experience across oral solid dosage forms. Supported HPRA audits/inspections (as applicable).
Deepak Bhattacharya
14 years driving quality excellence. Specialist in quality management systems and regulatory compliance.
Led deviations/CAPA + change control in EU GMP environments.
Sud Sunkaraneni
14 years building technology for regulated industries. Leading PharmaFlow's digital platform.
Built audit-ready systems for healthcare and fintech regulated environments.
Collectively: 50+ years across QP/QA/RA/tech operations
We do not claim to replace your legal responsibilities. We provide the operating system and execution coordination for compliant EU entry, where applicable and under the appropriate authorization framework.