β Refreshed to current state (2026-06-12):Entity name LOCKED β Navira Quality Systems Pvt Ltd (India) + Navira Quality Systems Inc (US); Verixa is the product. F0 is no longer an open A/B/C entity choice β the India launching entity is Navira Quality Systems Pvt Ltd (final structure + instrument pending counsel at Investor GATE 1). Founder is solo (CEO pathway: co-founder search β CRO at seed β exec-search CEO at A/B). Hiring here is target-state RACI and is reconciled against the seed budget in the investment tracker. EU remains out of scope.
20
India regulatory items
9
US FDA boundary items
8
Senior hires + advisors
12
GTM workstreams
90
Days to pilot-launch gate
π‘ Insights & Next Actions
Most urgent (F0): the India launching entity is Navira Quality Systems Pvt Ltd β confirm final structure + instrument at counsel (Investment GATE 1). Everything downstream depends on it.
Highest-leverage launch decision: lock 3 named design partners (Founder-Advisor flag). VX-CDSCO-001 is the 10-day marquee artifact that unblocks Indian-sponsor onboarding β authorize it now.
Day-90 gate needs: F0 closed Β· β₯2 design partners active Β· mock audit pass Β· Head of QA + DPO onboarded Β· ISO 27001 stage-2 scheduled Β· cyber insurance bound. These design-partner commitments ARE Investment GATE 2 evidence.
Scope discipline: India + US FDA only, no EU (saves ~30% effort / ~40% cert cost). MIRA stays advisory-only β avoids the FDA-483 AI-overreliance risk the warning letter flagged.