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Unify external contract manufacturing plants, batch COA release, shade card approvals, and country registrations under 21 CFR Part 11
Virtual pharmaceutical marketing companies, merchant exporters, and loan-license operators run lean commercial operations while coordinating multiple third-party contract development and manufacturing organizations (CDMOs), packaging printers, and foreign health authorities across MENA, CIS, ASEAN, and Africa. Traditional enterprise platforms (Veeva, TrackWise) penalize this distributed model with steep per-user seat fees, forcing critical batch reviews and artwork sign-offs into unvalidated email threads and WhatsApp chats. Novaqis delivers a unified, 21 CFR Part 11 validated quality, document, and regulatory suite with flat site licensing—giving external CDMOs, printers, and internal QA a single governed workspace.
Product preview
Milestone tracking and 180/90/30-day renewal countdowns across global export destinations
| 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.
Eliminate emailed PDF batch certificates. External CDMOs securely upload Certificate of Analysis (COA) documents, analytical raw data, and batch manufacturing summaries directly into Novaqis DMS and QMS. Automated specification interlocks verify potency, impurities, and dissolution before Qualified Person (QP) disposition.
Coordinate supplier-initiated changes (raw material source, manufacturing equipment, batch scale) through Novaqis QMS. Automated risk-scoring trees evaluate regulatory impact across all registered country Marketing Authorizations before changes are authorized.
Track registration milestones (Dossier Prep, Submitted, Query Responded, Approved) across semi-regulated, MENA, CIS, ASEAN, and African authorities. Automated 180/90/30-day renewal alerts prevent export container rejections and customs seizures.
Bridge approved SmPC and Package Inserts directly to packaging die-lines, foil prints, and cartons. Replace casual WhatsApp shade-card sign-offs with character-level text diffing, vector PDF inspection, and cryptographic e-signatures.
Maintain audit histories, quality agreements, and compliance scorecards for all loan-license manufacturing sites. Live Inspection Room Mode allows rapid evidence compilation during foreign regulatory or WHO GMP inspections.
Invite dozens of external CDMO plant managers, QA reviewers, prepress packaging artists, and overseas regulatory agents without per-user seat penalties, ensuring 100% of actions are recorded in immutable audit logs.
Compliance & control
Audit trails, electronic signatures, role-based access, and deployment choices designed for GxP validation, not bolted on after the fact.
Strict RBAC partitions external CDMOs and packaging printers so they only view authorized product lines and records without exposing third-party data.
Every batch review, document upload, and artwork sign-off generates immutable SHA-256 hashed timestamps compliant with 21 CFR §11.10.
Zero artwork proofs can be dispatched to packaging printers without an approved, e-signed QMS Change Control ticket.
Configurable alert triggers at 180, 90, and 30 days prior to license expiry across all registered country dossiers.
Enterprise Outcomes
Measured operational breakthroughs across quality, manufacturing, and regulatory compliance.
Eliminate version discrepancies and obsolete packaging recalls across distributed CDMOs
Accelerate commercial batch disposition from 14 days of email back-and-forth to under 48 hours
Zero customs rejections or license lapses with automated 180/90/30-day renewal countdowns
Full 21 CFR Part 11 and EU Annex 11 inspection readiness for foreign health authority audits
Reduce regulatory and quality software TCO by up to 70% compared to legacy enterprise platforms
FAQ
