Verixa β Regulatory & Compliance Intelligence Tracker
π Patent-filing date realignment Β· 18 Jun β 26 Jun β 03 Jul 2026
Patent FD target shifted from 15 Jun 2026 to 26 Jun 2026 03 Jul 2026 . All FD+N statutory and decision dates shift accordingly: Β§39 clock starts 26 Jun 03 Jul Β· complete specifications due 26 Jun 2027 03 Jul 2027 (Β§9(1)) Β· PCT decision 26 Dec 2026 03 Jan 2027 Β· US/EU national-phase entry 26 Dec 2028 03 Jan 2029 Β· Request for Examination 26 Jan 2029 03 Feb 2029 . Marketing public-disclosure window also shifts: founder 1-to-1 outbound to known DP targets continues pre-FD under NDA; public marketing (newsletter Β· pillar pages Β· founder LinkedIn cadence Β· PR note Β· webinar invites) unlocks Mon 29 Jun 2026 Tue 07 Jul 2026 (W5) post-FD. Engineering W1-W14 pilot timeline holds: demo lock Fri 26 Jun Β· Verified Go-Live Decision Tue 01 Sep.
Applicable GxP regulations, guidance & laws Verixa is built to Β· GMPΒ·GCPΒ·GLPΒ·GDPΒ·GVPΒ·data integrityΒ·CSV/AI Β· GAMP 5 Cat-5 Β· owned by VRX-SOP-009 Β· jurisdictions: USΒ·EUΒ·UKΒ·IndiaΒ·Intl Β· development phase β advisory horizon-scan, no change control until verified, tested & validated
4
draft / emerging (AI-era)
5
jurisdictions (USΒ·EUΒ·UKΒ·IndiaΒ·Intl)
VRX-SOP-009
owns source mapping
Regulatory Source Library
Overview & Insights
GMP (cGMP & QMS) (12)
GCP & GLP (7)
GDP & GVP (7)
Data Integrity & e-Records (6)
CSV & AI (7)
ICH Quality (4)
Submissions & Biologics (3)
India & Privacy (4)
IP / Patent Law (2)
Governance
GxP regulatory horizon-scan, mapped to Verixa controls (SOP / URS). Source of truth for applicability = VRX-SOP-009 + VRX-SOP-008 GxP/GAMP-5 assessment. Conclusion fact- and jurisdiction-dependent β confirm current effective dates/applicability with qualified regulatory counsel before relying. Development phase: advisory; regulatory change feeds design, not change control, until verified, tested & validated. Not legal/regulatory advice.