What is Novaqis RIMS & Dossier Hub?

Novaqis RIMS & Dossier Hub is an enterprise Regulatory Information Management and Packaging Artwork system designed for mid-market pharmaceutical companies, virtual pharma marketing entities, merchant exporters, and loan-license operators. It centralizes country-wise Marketing Authorizations (MAs), CTD/ACTD Module 1–5 dossiers, automated 180/90/30-day renewal alerts, and bridges approved SmPC/Package Inserts directly to packaging artwork proofing and QMS Change Controls under 21 CFR Part 11 compliance.

How does artwork revision link to a change control record in Novaqis?

In Novaqis, packaging artwork revision control (Rev 01 → Rev 02) is cryptographically locked to an approved QMS Change Control record. When an SmPC, formulation, or packaging specification is updated, the Regulatory Impact Assessment automatically generates an impacted pack register. Prepress PDF proofs cannot be released to packaging printers or contract manufacturers without an authorized, e-signed Change Control ticket.

Does Novaqis support semi-regulated markets, MENA, CIS, and ASEAN ACTD formats?

Yes. Novaqis RIMS supports both ICH CTD (Modules 1–5) and ASEAN ACTD (Parts I–IV), alongside specific national registration formats for semi-regulated, MENA (GCC/SFDA), CIS (Uzbekistan, Kazakhstan, Russia), ASEAN (Philippines, Vietnam, Thailand, Malaysia, Indonesia), and African health authorities (NAFDAC, MCAZ, PPB, SAHPRA).

How do virtual pharma and loan-license operators manage multiple external CDMOs and packaging printers?

Because Novaqis charges zero per-user seat taxes, companies can invite external CDMO manufacturing heads, external QA reviewers, packaging printers, and foreign regulatory agents into secure, role-restricted portals. All document reviews, PDF artwork proof approvals, shade card verifications, and batch COA handshakes are executed with 21 CFR Part 11 compliant digital signatures and timestamped audit logs.

How does automated artwork proofing and PDF diffing prevent packaging errors?

Novaqis provides automated vector and pixel-level PDF diff comparison alongside character-level text inspection. The system overlays the approved SmPC or previous packaging revision against the printer's prepress proof, highlighting any millimeter-level die-line drift, missing statutory caution statements, modified barcodes, or unauthorized font modifications.

How are 180/90/30-day Marketing Authorization renewal alerts managed?

Novaqis RIMS tracks statutory renewal windows per country and procedure (National, Decentralised, Centralised). At configurable milestones (180, 90, 60, and 30 days prior to expiry), the system triggers automated alerts to Regulatory Affairs, commercial export heads, and supply chain teams, initiating dossier renewal preparation before foreign health authority deadlines expire.

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GxP-ready themes21 CFR Part 11EU Annex 11

NovaqisRIMS&DossierHubRegulatory Information Management (RIM) & Packaging Artwork Hub

Regulatory Affairs, CTD/ACTD Dossiers & Packaging Artwork Platform

Novaqis RIM is a 21 CFR Part 11 compliant regulatory information management system and dossier hub designed for Regulatory Affairs (RA) Directors, Merchant Exporters, and Loan-License Brand Owners. It solves foreign market registration blind spots, CTD/ACTD dossier sprawl, and packaging revision disconnects by synchronizing 40+ country Marketing Authorizations, automated 180/90/30-day renewal alerts, and native packaging artwork dieline proofing on a single compliant data fabric, eliminating legacy enterprise seat taxes and point-solution integration failures.

Country-wise Marketing Authorization (MA) Tracker
Automated 180/90/30-Day Renewal Notification Engine
Granular CTD & ACTD Module 1–5 Hierarchy Linked to DMS
Native Bridge between Approved SmPC and Packaging Artwork

Schedule a Demo GxP Tools Hub All Products

Novaqis RIMS & Dossier Hub · Global Registration Console21 CFR Part 11 & EU Annex 11 Validated · Zero Seat Tax

142 Active Country MAs4 Renewals in 90-Day Window

Total Registrations

142 MAs

28 Export Markets (MENA, ASEAN, CIS)

Dossiers in Assembly

19 Sequences

ICH CTD (12) · ASEAN ACTD (7)

Artwork Revisions Active

7 Pack Types

Linked to QMS Change Control

Connected CDMOs & Printers

14 External Partners

Role-gated · $0 Per-Seat Tax

Marketing Authorization Registry · Milestone TrackingAutomated 180 / 90 / 30-Day Expiry Countdown Active

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)

SHA-256 Hash: 9f8a2c114e7... · Part 11 CertifiedInspection Ready

At a glance

142 MAsGlobal registration tracking

180/90/30Proactive renewal alerts

SmPC → ArtAutomated die-line impact

CTD/ACTDModules 1–5 linked to DMS

Novaqis RIMS & Dossier Hub · Global Registration Console21 CFR Part 11 & EU Annex 11 Validated · Zero Seat Tax

142 Active Country MAs4 Renewals in 90-Day Window

Total Registrations

142 MAs

28 Export Markets (MENA, ASEAN, CIS)

Dossiers in Assembly

19 Sequences

ICH CTD (12) · ASEAN ACTD (7)

Artwork Revisions Active

7 Pack Types

Linked to QMS Change Control

Connected CDMOs & Printers

14 External Partners

Role-gated · $0 Per-Seat Tax

Marketing Authorization Registry · Milestone TrackingAutomated 180 / 90 / 30-Day Expiry Countdown Active

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)

SHA-256 Hash: 9f8a2c114e7... · Part 11 CertifiedInspection Ready

At a glance

142 MAsGlobal registration tracking

180/90/30Proactive renewal alerts

SmPC → ArtAutomated die-line impact

CTD/ACTDModules 1–5 linked to DMS

Enterprise Architecture

Platform capabilities grounded in how you validate and operate

Deterministic architectures and automated compliance engines engineered for multi-plant pharma operations.

Tier-1 Core Architecture

Country-wise Marketing Authorization (MA) Tracker

Maintain a centralized, real-time register of product registrations, local authorization numbers, MAH entities, local technical representatives (LTR), and authority approval milestones across every export destination.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Regulatory Interlock

Automated 180/90/30-Day Renewal Notification Engine

Proactive, automated notifications alert Regulatory Affairs and Commercial teams at 180, 90, and 30 days prior to license expiry, eliminating costly customs holds, port rejections, and re-registration penalties.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Granular CTD & ACTD Module 1–5 Hierarchy Linked to DMS

Assemble, validate, and version dossier structures for ICH CTD (Modules 1–5) and ASEAN ACTD (Parts I–IV) with lifecycle operators (new, replace, append, delete) natively bound to approved Novaqis DMS document versions.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Native Bridge between Approved SmPC and Packaging Artwork

When core or local Summary of Product Characteristics (SmPC), Package Inserts (PI), or Patient Information Leaflets (PIL) change, our Regulatory Impact Engine instantly identifies and flags all associated cartons, labels, foils, and die-lines.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Vector & Pixel PDF Proofing with Character Diffing

Detect millimeter-level die-line shifts, missing regulatory warning statements, font size deviations, and color separation errors between Rev 01 and Rev 02 artwork proofs with automated vector/pixel comparison.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Strict QMS Change Control Interlocks

Zero packaging artwork can be released for commercial printing without an approved, cryptographically signed Change Control record from Novaqis QMS, ensuring complete audit readiness during foreign regulatory inspections.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Multi-CDMO & External Printer Digital Collaboration

Provide external loan-license CDMOs, packaging printers, and regulatory agents secure, role-restricted portals to review proofs, submit shade card approvals, and download released print masters without per-seat licensing penalties.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Health Authority Interactions & Commitments Log

Track health authority deficiency letters, official query response deadlines, and post-approval regulatory commitments with end-to-end accountability and traceable response dossiers.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Cryptographic 21 CFR Part 11 & EU Annex 11 Compliance

Server-side SHA-256 hashed audit trails, dual-signature approval ceremonies, strict segregation of duties, and time-stamped change logs valid under US FDA, WHO GMP, and PIC/S inspections.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Zero Per-User Seat Taxes for Distributed Operations

Collaborate freely with dozens of contract manufacturing plants, external graphic artists, and overseas regulatory agents without punitive per-seat user fees.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

In the product

Country MAs, CTD/ACTD Dossiers & Packaging Artwork Bridge

Centralize global marketing authorizations, automate 180/90/30-day renewal alerts, version CTD/ACTD Modules 1–5 linked to DMS, and prevent packaging errors with automated SmPC-to-artwork proofing and QMS Change Control interlocks.

142 MAs

Global registration tracking

180/90/30

Proactive renewal alerts

SmPC → Art

Automated die-line impact

CTD/ACTD

Modules 1–5 linked to DMS

MA Registry & Alerts

Country-Wise Marketing Authorization & 180/90/30-Day Renewal Engine

Novaqis RIMS & Dossier Hub · Global Registration Console21 CFR Part 11 & EU Annex 11 Validated · Zero Seat Tax

142 Active Country MAs4 Renewals in 90-Day Window

Total Registrations

142 MAs

28 Export Markets (MENA, ASEAN, CIS)

Dossiers in Assembly

19 Sequences

ICH CTD (12) · ASEAN ACTD (7)

Artwork Revisions Active

7 Pack Types

Linked to QMS Change Control

Connected CDMOs & Printers

14 External Partners

Role-gated · $0 Per-Seat Tax

Marketing Authorization Registry · Milestone TrackingAutomated 180 / 90 / 30-Day Expiry Countdown Active

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)

SHA-256 Hash: 9f8a2c114e7... · Part 11 CertifiedInspection Ready

Govern market authorizations across MENA, CIS, ASEAN, and African health authorities with automated milestone tracking and proactive 180/90/30-day expiry notifications.

Dossier & Artwork Bridge

CTD/ACTD Module Repository & Native SmPC-to-Artwork Revision Diff

Novaqis RIMS & Dossier Hub · Global Registration Console21 CFR Part 11 & EU Annex 11 Validated · Zero Seat Tax

142 Active Country MAs4 Renewals in 90-Day Window

Total Registrations

142 MAs

28 Export Markets (MENA, ASEAN, CIS)

Dossiers in Assembly

19 Sequences

ICH CTD (12) · ASEAN ACTD (7)

Artwork Revisions Active

7 Pack Types

Linked to QMS Change Control

Connected CDMOs & Printers

14 External Partners

Role-gated · $0 Per-Seat Tax

Marketing Authorization Registry · Milestone TrackingAutomated 180 / 90 / 30-Day Expiry Countdown Active

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)

SHA-256 Hash: 9f8a2c114e7... · Part 11 CertifiedInspection Ready

Centrally assemble ICH CTD and ASEAN ACTD Modules 1–5 linked to DMS, and bridge approved SmPC text directly to packaging artwork die-lines and QMS Change Control.

Interactive Impact Cascade

Experience the Native RIM ↔ AMS ↔ QMS Bridge

Select a regulatory scenario below to watch how SmPC updates automatically trigger QMS Change Control, lock packaging components, and notify commercial printers.

Interactive Architectural Simulator RIM $\leftrightarrow$ AMS $\leftrightarrow$ QMS

Regulatory-to-Artwork Impact Cascade Simulator

Experience how a single regulatory SmPC change or supplier shift automatically triggers QMS Change Control, freezes packaging artwork dielines, and notifies external prepress printers.

Select Regulatory Trigger Event:

Stage 1: RIM Regulatory IntakeVARIATION REQUIRED

Saudi MA-49102-KSA Flagged & SmPC Section 4.4 Updated

Target SKU: CardioNov 20mg Film-Coated Tablets (Saudi Market)

Regulatory Affairs amends the bilingual Arabic/English SmPC Section 4.4 and Package Leaflet. The system automatically cross-references the Saudi Marketing Authorization and triggers the variation workflow.

MA ReferenceMA-49102-KSA (SFDA)

SmPC SectionSection 4.4: Special Warnings

FormatICH eCTD Module 1.3.1 (KSA)

LanguageBilingual (Arabic / English)

21 CFR Part 11 Immutable Audit Stamp: 2026-10-07 08:14:22 UTC · Dr. Salma Al-Harbi (Lead RA Specialist, SFDA Region)

Hash: SHA-256: 4f9c8d...77e1a

Zero Middleware Fragility: RIMS, QMS, and Artwork operate on one unified relational database. No Zapier, MuleSoft, or CSV batch syncs required.

Explore Artwork AMS Request Live Demo

Capability depth

Country Registrations, CTD/ACTD Dossiers & Packaging Artwork Bridge

Engineered for mid-market pharmaceutical enterprises, virtual pharma marketing holders, merchant exporters, and loan-license operators. Novaqis RIMS unifies foreign market authorizations, CTD/ACTD Module 1–5 assembly, health authority interactions, and packaging artwork revision proofing across multiple external CDMOs and packaging printers with zero per-user seat taxes.

Country Registrations & Expiry Forecasting

Country-wise Marketing Authorization (MA) register across semi-regulated, MENA, CIS, ASEAN, and African health authorities
Milestone status tracking: Dossier Preparation, Submitted, Health Authority Queries, Approved, and Variation
Automated 180-day, 90-day, and 30-day proactive renewal alerts preventing export license lapses and supply chain freezes
Health authority interactions tracker: deficiency letters, formal question-response workflows, and post-approval commitment registers
Multi-role stakeholder governance: Marketing Authorization Holder (MAH), Local Technical Representative (LTR / Agent), CDMO manufacturing sites, and distributors

CTD & ACTD Dossier Management

Hierarchical Module 1–5 repository supporting both ICH CTD (Modules 1–5) and ASEAN ACTD (Parts I–IV) structures
Lifecycle operators (new, replace, append, delete) with granular document versioning and sequence traceability
Native bridge to Novaqis DMS: direct linkage to approved document numbers and revisions without duplicated uploads
Variation management (Major, Minor Type IA/IB, Type II) with instant cross-country dossier impact matrices
Cryptographic export bundles and inspection-ready submission archives with complete audit trails

Packaging Artwork Bridge & Revision Control

Native Regulatory Impact Assessment: modifications in SmPC, Package Insert (PI), or PIL trigger automated flags on affected packaging die-lines, cartons, labels, and blister foils
Bi-directional interlock with Novaqis QMS Change Control: artwork revisions (Rev 01 → Rev 02) cannot advance to commercial print without an authorized CC record
Multi-stakeholder external review portal: RA, QA, Medical, Legal, CDMO, and external prepress packaging printers review simultaneously
Vector/pixel PDF diffing and character-level font/text comparison catching millimeter-level die-line shifts or missing statutory warnings
Prepress cylinder sign-off, pantone shade card approvals, and obsolete packaging recall registers preventing scrap and misbranding

Enterprise Benchmark & Architecture

Why Growing Life Sciences Firms Standardize on Novaqis RIMS & Artwork Hub

Enterprise monoliths like Veeva Vault RIM or Ennov impose steep per-user seat taxes and force fragmented workflows across separate regulatory, quality, and artwork applications. Novaqis RIMS unifies country registrations, CTD/ACTD dossier assembly, QMS change control, and packaging artwork proofing into one validated, high-availability architecture tailored for mid-market pharma, virtual marketing entities, and loan-license operators.

Dimension

Legacy Enterprise Monoliths & Point Tools

Novaqis RIMS & Dossier Hub

Architecture Evaluation Checklist

Licensing Model & Multi-CDMO/Printer Collaboration

Per-user seat taxes vs unlimited ecosystem access

Read full comparison

High per-user seat fees ($2,500–$4,500/user/yr), locking out external CDMOs and packaging printers.

Flat site/tenant licensing with unlimited internal and external collaborator seats ($0 seat tax).

Invite external CDMO QA and packaging printer prepress teams to a live review.
Verify zero per-seat licensing cost impact when scaling partner networks.

SmPC to Packaging Artwork Native Bridge

Manual coordination across email vs automated regulatory impact triggers

Read full comparison

Siloed documents; SmPC updates in Word documents rarely flag existing packaging die-lines.

Automated Regulatory Impact Engine linking SmPC sections directly to pack presentations and die-lines.

Simulate an SmPC storage condition revision and observe automated pack impact alerts.
Trace the linked impact record from Regulatory Affairs to Packaging Artwork.

QMS Change Control Interlock

Loose procedural promises vs hard system-enforced gates

Read full comparison

Separate QMS and Artwork tools; printers receive files before change control is formally closed.

Cryptographic fail-closed interlock: artwork cannot advance to print without approved Change Control.

Attempt to release artwork revision Rev 02 without a linked Change Control record.
Verify automated closure synchronization between QMS and RIMS.

CTD & ACTD Dossier Assembly & DMS Integration

Clunky manual PDF mergers vs versioned CTD/ACTD node lifecycle linked to DMS

Read full comparison

Complex publishing tools requiring external consultants for basic sequence creation.

Native Module 1–5 hierarchy with direct link to approved Novaqis DMS documents.

Assemble a 5-module CTD structure pulling source documents directly from DMS.
Verify sequence versioning and lifecycle operator audit logs.

Vector & Character-Level Artwork Proofing

Eyeball proofreading vs automated vector/pixel comparison

Read full comparison

Manual visual inspection of printed proofs, prone to human fatigue and missed typo errors.

Built-in digital proofing with character-level text diffing and vector/pixel overlay comparison.

Upload a modified carton PDF proof and inspect automated character and pixel diff flags.
Verify shade card approval and cylinder sign-off registers.

High per-user seat fees ($2,500–$4,500/user/yr), locking out external CDMOs and packaging printers.

Flat site/tenant licensing with unlimited internal and external collaborator seats ($0 seat tax).

Architecture Evaluation Checklist

Invite external CDMO QA and packaging printer prepress teams to a live review.

+1 more evaluation item in the full comparison - expand above.

Siloed documents; SmPC updates in Word documents rarely flag existing packaging die-lines.

Automated Regulatory Impact Engine linking SmPC sections directly to pack presentations and die-lines.

Architecture Evaluation Checklist

Simulate an SmPC storage condition revision and observe automated pack impact alerts.

+1 more evaluation item in the full comparison - expand above.

Separate QMS and Artwork tools; printers receive files before change control is formally closed.

Cryptographic fail-closed interlock: artwork cannot advance to print without approved Change Control.

Architecture Evaluation Checklist

Attempt to release artwork revision Rev 02 without a linked Change Control record.

+1 more evaluation item in the full comparison - expand above.

Complex publishing tools requiring external consultants for basic sequence creation.

Native Module 1–5 hierarchy with direct link to approved Novaqis DMS documents.

Architecture Evaluation Checklist

Assemble a 5-module CTD structure pulling source documents directly from DMS.

+1 more evaluation item in the full comparison - expand above.

Manual visual inspection of printed proofs, prone to human fatigue and missed typo errors.

Built-in digital proofing with character-level text diffing and vector/pixel overlay comparison.

Architecture Evaluation Checklist

Upload a modified carton PDF proof and inspect automated character and pixel diff flags.

+1 more evaluation item in the full comparison - expand above.

Comparison reflects standard market configurations and licensing structures. Your specific validation requirements govern all decisions.

Full suite evaluation guide Schedule a demo

Regulatory alignment

Built for inspections from day one

21 CFR Part 11 themesEU Annex 11 / GMP themesALCOA+ data integrityValidation-ready deployment

Technical Research

Architecture & Compliance Guides

Top 10 Pharma LIMS Software & Enterprise QC Laboratory Benchmark (2026)Inspection Readiness Without Binder Archaeology: US FDA & WHO GMP Audit Architecture

Next step

Tools & contact

Talk to Novaqis

Ready to see Novaqis RIMS & Dossier Hub in action?

Talk to our team about how Novaqis RIMS & Dossier Hub fits your validation and compliance requirements.

Schedule a Demo Suite integrations GxP decision tools Explore all products

FAQ

Novaqis RIMS & Dossier Hub FAQ

: Novaqis RIMS & Dossier Hub is an enterprise Regulatory Information Management and Packaging Artwork system designed for mid-market pharmaceutical companies, virtual pharma marketing entities, merchant exporters, and loan-license operators. It centralizes country-wise Marketing Authorizations (MAs), CTD/ACTD Module 1–5 dossiers, automated 180/90/30-day renewal alerts, and bridges approved SmPC/Package Inserts directly to packaging artwork proofing and QMS Change Controls under 21 CFR Part 11 compliance.

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GxP-ready themes21 CFR Part 11EU Annex 11

NovaqisRIMS&DossierHubRegulatory Information Management (RIM) & Packaging Artwork Hub

Regulatory Affairs, CTD/ACTD Dossiers & Packaging Artwork Platform

Country-wise Marketing Authorization (MA) Tracker
Automated 180/90/30-Day Renewal Notification Engine
Granular CTD & ACTD Module 1–5 Hierarchy Linked to DMS
Native Bridge between Approved SmPC and Packaging Artwork

Schedule a Demo GxP Tools Hub All Products

Novaqis RIMS & Dossier Hub · Global Registration Console21 CFR Part 11 & EU Annex 11 Validated · Zero Seat Tax

142 Active Country MAs4 Renewals in 90-Day Window

Total Registrations

142 MAs

28 Export Markets (MENA, ASEAN, CIS)

Dossiers in Assembly

19 Sequences

ICH CTD (12) · ASEAN ACTD (7)

Artwork Revisions Active

7 Pack Types

Linked to QMS Change Control

Connected CDMOs & Printers

14 External Partners

Role-gated · $0 Per-Seat Tax

Marketing Authorization Registry · Milestone TrackingAutomated 180 / 90 / 30-Day Expiry Countdown Active

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)

SHA-256 Hash: 9f8a2c114e7... · Part 11 CertifiedInspection Ready

At a glance

142 MAsGlobal registration tracking

180/90/30Proactive renewal alerts

SmPC → ArtAutomated die-line impact

CTD/ACTDModules 1–5 linked to DMS

Novaqis RIMS & Dossier Hub · Global Registration Console21 CFR Part 11 & EU Annex 11 Validated · Zero Seat Tax

142 Active Country MAs4 Renewals in 90-Day Window

Total Registrations

142 MAs

28 Export Markets (MENA, ASEAN, CIS)

Dossiers in Assembly

19 Sequences

ICH CTD (12) · ASEAN ACTD (7)

Artwork Revisions Active

7 Pack Types

Linked to QMS Change Control

Connected CDMOs & Printers

14 External Partners

Role-gated · $0 Per-Seat Tax

Marketing Authorization Registry · Milestone TrackingAutomated 180 / 90 / 30-Day Expiry Countdown Active

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)

SHA-256 Hash: 9f8a2c114e7... · Part 11 CertifiedInspection Ready

At a glance

142 MAsGlobal registration tracking

180/90/30Proactive renewal alerts

SmPC → ArtAutomated die-line impact

CTD/ACTDModules 1–5 linked to DMS

Enterprise Architecture

Platform capabilities grounded in how you validate and operate

Deterministic architectures and automated compliance engines engineered for multi-plant pharma operations.

Tier-1 Core Architecture

Country-wise Marketing Authorization (MA) Tracker

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Regulatory Interlock

Automated 180/90/30-Day Renewal Notification Engine

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Granular CTD & ACTD Module 1–5 Hierarchy Linked to DMS

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Native Bridge between Approved SmPC and Packaging Artwork

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Vector & Pixel PDF Proofing with Character Diffing

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Strict QMS Change Control Interlocks

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Multi-CDMO & External Printer Digital Collaboration

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Health Authority Interactions & Commitments Log

Track health authority deficiency letters, official query response deadlines, and post-approval regulatory commitments with end-to-end accountability and traceable response dossiers.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Cryptographic 21 CFR Part 11 & EU Annex 11 Compliance

Server-side SHA-256 hashed audit trails, dual-signature approval ceremonies, strict segregation of duties, and time-stamped change logs valid under US FDA, WHO GMP, and PIC/S inspections.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

Operational Standard

Zero Per-User Seat Taxes for Distributed Operations

Collaborate freely with dozens of contract manufacturing plants, external graphic artists, and overseas regulatory agents without punitive per-seat user fees.

21 CFR Part 11 · GAMP 5 Cat 4Deterministic Control

In the product

Country MAs, CTD/ACTD Dossiers & Packaging Artwork Bridge

142 MAs

Global registration tracking

180/90/30

Proactive renewal alerts

SmPC → Art

Automated die-line impact

CTD/ACTD

Modules 1–5 linked to DMS

MA Registry & Alerts

Country-Wise Marketing Authorization & 180/90/30-Day Renewal Engine

Novaqis RIMS & Dossier Hub · Global Registration Console21 CFR Part 11 & EU Annex 11 Validated · Zero Seat Tax

142 Active Country MAs4 Renewals in 90-Day Window

Total Registrations

142 MAs

28 Export Markets (MENA, ASEAN, CIS)

Dossiers in Assembly

19 Sequences

ICH CTD (12) · ASEAN ACTD (7)

Artwork Revisions Active

7 Pack Types

Linked to QMS Change Control

Connected CDMOs & Printers

14 External Partners

Role-gated · $0 Per-Seat Tax

Marketing Authorization Registry · Milestone TrackingAutomated 180 / 90 / 30-Day Expiry Countdown Active

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)

SHA-256 Hash: 9f8a2c114e7... · Part 11 CertifiedInspection Ready

Govern market authorizations across MENA, CIS, ASEAN, and African health authorities with automated milestone tracking and proactive 180/90/30-day expiry notifications.

Dossier & Artwork Bridge

CTD/ACTD Module Repository & Native SmPC-to-Artwork Revision Diff

Novaqis RIMS & Dossier Hub · Global Registration Console21 CFR Part 11 & EU Annex 11 Validated · Zero Seat Tax

142 Active Country MAs4 Renewals in 90-Day Window

Total Registrations

142 MAs

28 Export Markets (MENA, ASEAN, CIS)

Dossiers in Assembly

19 Sequences

ICH CTD (12) · ASEAN ACTD (7)

Artwork Revisions Active

7 Pack Types

Linked to QMS Change Control

Connected CDMOs & Printers

14 External Partners

Role-gated · $0 Per-Seat Tax

Marketing Authorization Registry · Milestone TrackingAutomated 180 / 90 / 30-Day Expiry Countdown Active

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)

SHA-256 Hash: 9f8a2c114e7... · Part 11 CertifiedInspection Ready

Centrally assemble ICH CTD and ASEAN ACTD Modules 1–5 linked to DMS, and bridge approved SmPC text directly to packaging artwork die-lines and QMS Change Control.

Interactive Impact Cascade

Experience the Native RIM ↔ AMS ↔ QMS Bridge

Select a regulatory scenario below to watch how SmPC updates automatically trigger QMS Change Control, lock packaging components, and notify commercial printers.

Interactive Architectural Simulator RIM $\leftrightarrow$ AMS $\leftrightarrow$ QMS

Regulatory-to-Artwork Impact Cascade Simulator

Experience how a single regulatory SmPC change or supplier shift automatically triggers QMS Change Control, freezes packaging artwork dielines, and notifies external prepress printers.

Select Regulatory Trigger Event:

Stage 1: RIM Regulatory IntakeVARIATION REQUIRED

Saudi MA-49102-KSA Flagged & SmPC Section 4.4 Updated

Target SKU: CardioNov 20mg Film-Coated Tablets (Saudi Market)

MA ReferenceMA-49102-KSA (SFDA)

SmPC SectionSection 4.4: Special Warnings

FormatICH eCTD Module 1.3.1 (KSA)

LanguageBilingual (Arabic / English)

21 CFR Part 11 Immutable Audit Stamp: 2026-10-07 08:14:22 UTC · Dr. Salma Al-Harbi (Lead RA Specialist, SFDA Region)

Hash: SHA-256: 4f9c8d...77e1a

Zero Middleware Fragility: RIMS, QMS, and Artwork operate on one unified relational database. No Zapier, MuleSoft, or CSV batch syncs required.

Explore Artwork AMS Request Live Demo

Capability depth

Country Registrations, CTD/ACTD Dossiers & Packaging Artwork Bridge

Country Registrations & Expiry Forecasting

Country-wise Marketing Authorization (MA) register across semi-regulated, MENA, CIS, ASEAN, and African health authorities
Milestone status tracking: Dossier Preparation, Submitted, Health Authority Queries, Approved, and Variation
Automated 180-day, 90-day, and 30-day proactive renewal alerts preventing export license lapses and supply chain freezes
Health authority interactions tracker: deficiency letters, formal question-response workflows, and post-approval commitment registers
Multi-role stakeholder governance: Marketing Authorization Holder (MAH), Local Technical Representative (LTR / Agent), CDMO manufacturing sites, and distributors

CTD & ACTD Dossier Management

Hierarchical Module 1–5 repository supporting both ICH CTD (Modules 1–5) and ASEAN ACTD (Parts I–IV) structures
Lifecycle operators (new, replace, append, delete) with granular document versioning and sequence traceability
Native bridge to Novaqis DMS: direct linkage to approved document numbers and revisions without duplicated uploads
Variation management (Major, Minor Type IA/IB, Type II) with instant cross-country dossier impact matrices
Cryptographic export bundles and inspection-ready submission archives with complete audit trails

Packaging Artwork Bridge & Revision Control

Native Regulatory Impact Assessment: modifications in SmPC, Package Insert (PI), or PIL trigger automated flags on affected packaging die-lines, cartons, labels, and blister foils
Bi-directional interlock with Novaqis QMS Change Control: artwork revisions (Rev 01 → Rev 02) cannot advance to commercial print without an authorized CC record
Multi-stakeholder external review portal: RA, QA, Medical, Legal, CDMO, and external prepress packaging printers review simultaneously
Vector/pixel PDF diffing and character-level font/text comparison catching millimeter-level die-line shifts or missing statutory warnings
Prepress cylinder sign-off, pantone shade card approvals, and obsolete packaging recall registers preventing scrap and misbranding

Enterprise Benchmark & Architecture

Why Growing Life Sciences Firms Standardize on Novaqis RIMS & Artwork Hub

Dimension

Legacy Enterprise Monoliths & Point Tools

Novaqis RIMS & Dossier Hub

Architecture Evaluation Checklist

Licensing Model & Multi-CDMO/Printer Collaboration

Per-user seat taxes vs unlimited ecosystem access

Read full comparison

High per-user seat fees ($2,500–$4,500/user/yr), locking out external CDMOs and packaging printers.

Flat site/tenant licensing with unlimited internal and external collaborator seats ($0 seat tax).

Invite external CDMO QA and packaging printer prepress teams to a live review.
Verify zero per-seat licensing cost impact when scaling partner networks.

SmPC to Packaging Artwork Native Bridge

Manual coordination across email vs automated regulatory impact triggers

Read full comparison

Siloed documents; SmPC updates in Word documents rarely flag existing packaging die-lines.

Automated Regulatory Impact Engine linking SmPC sections directly to pack presentations and die-lines.

Simulate an SmPC storage condition revision and observe automated pack impact alerts.
Trace the linked impact record from Regulatory Affairs to Packaging Artwork.

QMS Change Control Interlock

Loose procedural promises vs hard system-enforced gates

Read full comparison

Separate QMS and Artwork tools; printers receive files before change control is formally closed.

Cryptographic fail-closed interlock: artwork cannot advance to print without approved Change Control.

Attempt to release artwork revision Rev 02 without a linked Change Control record.
Verify automated closure synchronization between QMS and RIMS.

CTD & ACTD Dossier Assembly & DMS Integration

Clunky manual PDF mergers vs versioned CTD/ACTD node lifecycle linked to DMS

Read full comparison

Complex publishing tools requiring external consultants for basic sequence creation.

Native Module 1–5 hierarchy with direct link to approved Novaqis DMS documents.

Assemble a 5-module CTD structure pulling source documents directly from DMS.
Verify sequence versioning and lifecycle operator audit logs.

Vector & Character-Level Artwork Proofing

Eyeball proofreading vs automated vector/pixel comparison

Read full comparison

Manual visual inspection of printed proofs, prone to human fatigue and missed typo errors.

Built-in digital proofing with character-level text diffing and vector/pixel overlay comparison.

Upload a modified carton PDF proof and inspect automated character and pixel diff flags.
Verify shade card approval and cylinder sign-off registers.

High per-user seat fees ($2,500–$4,500/user/yr), locking out external CDMOs and packaging printers.

Flat site/tenant licensing with unlimited internal and external collaborator seats ($0 seat tax).

Architecture Evaluation Checklist

Invite external CDMO QA and packaging printer prepress teams to a live review.

+1 more evaluation item in the full comparison - expand above.

Siloed documents; SmPC updates in Word documents rarely flag existing packaging die-lines.

Automated Regulatory Impact Engine linking SmPC sections directly to pack presentations and die-lines.

Architecture Evaluation Checklist

Simulate an SmPC storage condition revision and observe automated pack impact alerts.

+1 more evaluation item in the full comparison - expand above.

Separate QMS and Artwork tools; printers receive files before change control is formally closed.

Cryptographic fail-closed interlock: artwork cannot advance to print without approved Change Control.

Architecture Evaluation Checklist

Attempt to release artwork revision Rev 02 without a linked Change Control record.

+1 more evaluation item in the full comparison - expand above.

Complex publishing tools requiring external consultants for basic sequence creation.

Native Module 1–5 hierarchy with direct link to approved Novaqis DMS documents.

Architecture Evaluation Checklist

Assemble a 5-module CTD structure pulling source documents directly from DMS.

+1 more evaluation item in the full comparison - expand above.

Manual visual inspection of printed proofs, prone to human fatigue and missed typo errors.

Built-in digital proofing with character-level text diffing and vector/pixel overlay comparison.

Architecture Evaluation Checklist

Upload a modified carton PDF proof and inspect automated character and pixel diff flags.

+1 more evaluation item in the full comparison - expand above.

Comparison reflects standard market configurations and licensing structures. Your specific validation requirements govern all decisions.

Full suite evaluation guide Schedule a demo

Regulatory alignment

Built for inspections from day one

21 CFR Part 11 themesEU Annex 11 / GMP themesALCOA+ data integrityValidation-ready deployment

Technical Research

Architecture & Compliance Guides

Top 10 Pharma LIMS Software & Enterprise QC Laboratory Benchmark (2026)Inspection Readiness Without Binder Archaeology: US FDA & WHO GMP Audit Architecture

Next step

Tools & contact

Talk to Novaqis

Ready to see Novaqis RIMS & Dossier Hub in action?

Talk to our team about how Novaqis RIMS & Dossier Hub fits your validation and compliance requirements.

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FAQ

Novaqis RIMS & Dossier Hub FAQ

: Novaqis RIMS & Dossier Hub is an enterprise Regulatory Information Management and Packaging Artwork system designed for mid-market pharmaceutical companies, virtual pharma marketing entities, merchant exporters, and loan-license operators. It centralizes country-wise Marketing Authorizations (MAs), CTD/ACTD Module 1–5 dossiers, automated 180/90/30-day renewal alerts, and bridges approved SmPC/Package Inserts directly to packaging artwork proofing and QMS Change Controls under 21 CFR Part 11 compliance.