Export-Quality GMP. Built for India CDMOs.
India CDMOs carry dual compliance pressure — CDSCO and Schedule M at home, USFDA and global-client scrutiny abroad, and a widening AI evidence gap. Verixa Phase 1 GMP Core targets export-quality readiness. In Design-Partner Validation.
CMO Operations
Phase 1 GMP Core for India CDMOs balancing CDSCO obligations with USFDA and global-client expectations.
Export-Quality GMP Readiness
Phase 1 GMP Core targets the documentation and evidence trail India CDMOs need for USFDA, EU, and other global-client expectations — alongside CDSCO and Schedule M (revised January 2026) obligations at home.
Multi-Client Data Isolation
Complete data isolation between sponsor clients with shared GMP quality infrastructure. Each client sees only their product data, deviations, and findings.
Batch Record & Deviation Workflows
Multi-product batch record review with deviation, RCA, and CAPA workflows under 21 CFR Part 11-aligned controls — verified under our SDLC; the customer validates intended use.
Closing the AI Evidence Gap
MIRA is advisory and human-in-the-loop: it drafts and surfaces evidence, but your QA team makes every GxP-impactful decision — addressing the scrutiny global clients now apply to AI in quality systems.
INR-Denominated
Local pricing and contracting for India-based CDMOs.
AWS Mumbai Data Residency
Quality records hosted in-region, on AWS Mumbai infrastructure.
DPDP-Aware
Built with India’s Digital Personal Data Protection framework in mind.
Transparent, India-First Pricing
Priced by workflow
License the workflows you need — a First Workflow License (foundation included), Additional Workflow Licenses, or a Connected Workflow Pack. INR-denominated, scoped per deployment. Final pricing confirmed after design-partner validation. See the Pricing page.
By deployment scope
A Multi-Workflow / Multi-Site Agreement covers broader deployments — priced by workflow, not by seat count. Final pricing confirmed after design-partner validation. See the Pricing page.
Design Partner Program
A ₹9L pilot fee, which may be credited toward your annual license, subject to the commercial agreement. Design partners shape what we harden first.
Which workflow should Verixa map first?
Select one current quality process. We will show how Verixa could support it, where AI assists, where human decisions remain mandatory, and what validation responsibilities stay with your organization.