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. Architecture-complete and 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
₹30–150L + applicable GST
Site-anchored annual licence, INR-denominated, scoped to Phase 1 GMP Core. Final pricing confirmed post-design-partner validation.
$110K–$350K
Annual contract value, site-anchored with unlimited users in band. Final pricing confirmed post-design-partner validation.
Design Partner Program
A ₹9L pilot fee, 100% credited toward your Year-1 licence. Design partners shape what we harden first.
Ready to See Verixa in Action?
A focused walkthrough of Phase 1 GMP Core. 30 minutes. No obligations.