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Eliminate enterprise per-user seat taxes, multi-vault silos, and 12-month implementation cycles
Mid-market pharmaceutical manufacturers, virtual marketing companies, and emerging market exporters (operating across MENA, CIS, ASEAN, LATAM, and Africa) need regulatory compliance and data integrity—not enterprise price inflation. Novaqis delivers unified Regulatory Information Management (RIM), CTD/ACTD Modules 1–5, native browser packaging artwork proofing, eQMS, and external CDMO collaborator portals with transparent mid-market site licensing and $0 per-user seat penalties.
Product preview
Global registration lifecycle management with 180/90/30-day renewal countdown notifications
| Authority / Territory | Product & Strength | Format | Contract CDMO | Status | Renewal Alert |
|---|---|---|---|---|---|
| Saudi Arabia (SFDA) | Novapressin 40mg Tab | GCC Centralised | Apex Formulations (Plant 02) | Approved | 90 Days (Due Nov 2026) |
| Philippines (FDA) | Novapressin 40mg Tab | ASEAN ACTD | Medispan Parenterals | Approved | 180 Days (Active) |
| Uzbekistan (SSPHC) | Novapressin 40mg Tab | National | Apex Formulations (Plant 02) | Query Responded | Submission Under Review |
| Kenya (PPB) | Novapressin 40mg Tab | EAC Harmonized | Apex Formulations (Plant 02) | Approved | 30 Days (Urgent Action) |
Technical Architecture
Each capability is built directly into our shared regulatory fabric, eliminating integration glue and validation rework.
Replace Veeva's $3,000–$5,500/user/yr fees and $100k+ minimum thresholds with flat plant-wide site licensing or transparent modular SaaS. Grant individual validated accounts to all RA officers, QA specialists, and shop-floor personnel without rationing access.
Eliminate third-party graphic inspection add-ons ($30,000–$80,000+ extra). Novaqis natively performs vector/pixel PDF diffing, character-level text extraction, and automated SmPC-to-die-line impact analysis locked to QMS Change Control numbers.
Track country-by-country Marketing Authorizations across 50+ export destinations with automated 180, 90, and 30-day renewal warnings. Supports ASEAN ACTD (Parts I–IV), hybrid CTD Modules 1–5, and non-eCTD national submission formats.
Provide secure, role-restricted web portals where external contract manufacturers and packaging prepress houses upload batch COAs, review shade cards, and sign off on proofs under 21 CFR Part 11 e-signatures at zero added license cost.
Compliance & control
Audit trails, electronic signatures, role-based access, and deployment choices designed for GxP validation, not bolted on after the fact.
Flat enterprise site license with $0 per-user fees vs. $2,500–$5,500/user/yr legacy named seats.
Rapid 4–6 week deployment with automated GAMP 5 OQ vs. 9–14 months multi-phase consulting.
Native browser vector/pixel PDF diffing built into RIM vs. $30k–$80k third-party point tool add-ons.
Unlimited zero-fee collaborator portals with 21 CFR Part 11 dual-credential e-signatures.
Enterprise Outcomes
Measured operational breakthroughs across quality, manufacturing, and regulatory compliance.
Reduce 5-year Total Cost of Ownership by 60% to 70% compared to Veeva Vault and TrackWise
Go live in 4 to 6 weeks with pre-validated GAMP 5 Category 4 automated OQ test packs
Eliminate unvalidated WhatsApp and email chains for external batch COAs and packaging die-lines
Prevent export license expirations and customs rejections with automated 180/90/30-day renewal alerts
Deploy 100% on-premises in air-gapped plant networks or in customer-owned private cloud VPCs
FAQ
