International Regulatory Authority Intelligence & Dossier Management
Novaqis Regulatory Information Management (RIM) delivers a unified global regulatory tracker engineered for mid-market pharmaceutical manufacturers and merchant exporters. The platform centralizes Marketing Authorization lifecycles, automates 180/90/30-day renewal countdowns, maps territory-specific submission dossiers (ICH eCTD, ASEAN ACTD, EAEU Decision 78, and African national formats), and bridges approved labeling directly into packaging artwork proofing and regional serialization mandates.
Select Your Target Regulatory Jurisdiction
Explore submission formats, statutory renewal deadlines, packaging serialization requirements, and pre-configured dossier templates for leading export authorities.
Saudi Food and Drug Authority
Kingdom of Saudi Arabia (KSA) & GCC
Novaqis RIM provides end-to-end regulatory lifecycle management for pharmaceutical manufacturers and merchant exporters submitting to the Saudi Food and Drug Authority (SFDA). The platform automates Saudi eCTD Module 1 administrative workflows, monitors 5-year Marketing Authorization renewal deadlines with automated 180/90/30-day alerts, and bridges approved bilingual Arabic/English Package Inserts directly with RSD Tatmeen GS1 DataMatrix packaging serialization.
GCC & MENA Health Authorities
Middle East & North Africa (UAE MOHAP, Oman, Kuwait, Egypt EDA, Jordan JFDA)
Novaqis RIM centralizes regulatory lifecycle operations across GCC and MENA health authorities, including UAE MOHAP, Egypt EDA, Jordan JFDA, and Oman MOH. The platform manages multi-country Marketing Authorizations, coordinates Gulf Health Council (GHC) centralized tenders, automates bilingual Arabic/English packaging variations, and tracks regulatory submissions across transitioning eCTD and NeeS formats.
ASEAN Health Authorities
Southeast Asia (NPRA Malaysia, BPOM Indonesia, FDA Philippines, HSA Singapore, TFDA Thailand, DAV Vietnam)
Novaqis RIM streamlines pharmaceutical market authorizations across Southeast Asia by natively structuring ASEAN Common Technical Dossiers (ACTD Parts I–IV) for NPRA Malaysia, BPOM Indonesia, FDA Philippines, and TFDA Thailand. The system manages Zone IVb stability testing protocols, tracks localized labeling variations (Bahasa Melayu, Bahasa Indonesia, English, Thai), and provides automated 180/90/30-day renewal warnings for all ASEAN export licenses.
African Health Authorities & Harmonization
Sub-Saharan Africa (Tanzania TMDA, Nigeria NAFDAC, South Africa SAHPRA, Kenya PPB, Ghana FDA)
Novaqis RIM empowers pharmaceutical manufacturers and merchant exporters expanding across African health authorities, including Tanzania TMDA, Nigeria NAFDAC, South Africa SAHPRA, and Kenya PPB. The platform supports regional harmonization initiatives (EAC and SADC ZaZiBoNa), tracks fast-track regulatory reliance pathways based on WHO Prequalification or stringent regulatory authority (SRA) approvals, and prevents customs holds with automated license renewal forecasting.
CIS & Eurasian Economic Union
Eurasia (Russia Minzdrav, Kazakhstan NCEKS, Uzbekistan GUSP, Belarus, Azerbaijan)
Novaqis RIM unifies pharmaceutical registration and compliance across the Eurasian Economic Union (EAEU) and CIS territories. The platform streamlines EAEU Decision No. 78 unified dossier structuring, monitors mutual recognition and decentralized procedures across member states (Russia, Kazakhstan, Belarus, Armenia, Kyrgyzstan), tracks national-to-EAEU dossier transitions, and synchronizes Russian-language packaging proofing with Chestny ZNAK cryptographic DataMatrix serialization.
Central Drugs Standard Control Organisation
India (CDSCO & State Licensing Authorities / SLAs)
Novaqis RIM provides end-to-end regulatory compliance and license lifecycle management for Indian pharmaceutical manufacturers, loan-license brand marketers, and merchant exporters interacting with the Central Drugs Standard Control Organisation (CDSCO) and State Licensing Authorities (SLAs). The platform tracks SUGAM portal filings, monitors Form 25/28 manufacturing and loan-license renewal cycles, manages Certificate of Pharmaceutical Product (COPP) renewals, and enforces CDSCO Revised Schedule M computerized data integrity controls out-of-the-box.
Cross-Authority Dossier & Renewal Breakdown
Side-by-side comparison of submission standards, statutory expiry cycles, and serialization mandates across major export territories.
| Authority & Jurisdiction | Submission Format | Renewal Cadence | Packaging Barcode | Action |
|---|---|---|---|---|
| 🇸🇦 SFDA (Saudi Food and Drug Authority) Kingdom of Saudi Arabia (KSA) & GCC | eCTD v3.2.2 (Saudi Regional Specification Module 1) | 5 Years (Renewal dossier submission required 180 days prior to expiry) | GS1 DataMatrix 2D Barcode (GTIN, Expiry, Batch/Lot, Serial Number) aligned with SFDA RSD Tatmeen | Guide |
| 🇦🇪 GCC / MENA (GCC & MENA Health Authorities) Middle East & North Africa (UAE MOHAP, Oman, Kuwait, Egypt EDA, Jordan JFDA) | eCTD v3.2.2 (GCC Harmonized Module 1) / NeeS & Hybrid CTD (Egypt EDA, Jordan JFDA) | 5 Years across GCC / 3–5 Years in Egypt EDA and Levant territories | GS1 DataMatrix 2D Barcode (Tatmeen in UAE, GS1 Egypt national portal, GS1 Jordan) | Guide |
| 🇲🇾 ASEAN / ACTD (ASEAN Health Authorities) Southeast Asia (NPRA Malaysia, BPOM Indonesia, FDA Philippines, HSA Singapore, TFDA Thailand, DAV Vietnam) | ASEAN ACTD (Parts I–IV) / HSA Singapore eCTD | 5 Years (NPRA, BPOM, FDA Philippines) / 3 Years in Vietnam (DAV) | GS1 DataMatrix 2D Barcode (BPOM 2D QR Code mandate in Indonesia, GS1 Malaysia) | Guide |
| 🇹🇿 Africa / SADC / EAC (African Health Authorities & Harmonization) Sub-Saharan Africa (Tanzania TMDA, Nigeria NAFDAC, South Africa SAHPRA, Kenya PPB, Ghana FDA) | CTD Modules 1–5 / EAC Harmonized CTD / South Africa eSubmission (eCTD for SAHPRA) | 5 Years (TMDA, NAFDAC, PPB) / 3 Years in select Western/Central African markets | GS1 DataMatrix / GS1-128 / NAFDAC Mobile Authentication Service (MAS) scratch-off codes | Guide |
| 🇰🇿 CIS / EAEU (CIS & Eurasian Economic Union) Eurasia (Russia Minzdrav, Kazakhstan NCEKS, Uzbekistan GUSP, Belarus, Azerbaijan) | EAEU eCTD v1.0 (Decision of EEC Council No. 78) / National formats (Uzbekistan, Azerbaijan) | Initial registration valid for 5 Years; post-renewal granted with Unlimited (Perpetual) validity in EAEU | Chestny ZNAK Crypto-Code DataMatrix (Russia, Kazakhstan, Uzbekistan national serialization portals) | Guide |
| 🇮🇳 CDSCO (Central Drugs Standard Control Organisation) India (CDSCO & State Licensing Authorities / SLAs) | SUGAM Online Portal Electronic Filing / State Licensing Authority Portals (e-Aushadhi / FDCA) | 5 Years (Manufacturing licenses and Loan-Licenses under Drugs & Cosmetics Rules) / 3 Years for COPP | GS1 Barcoding for Export & Mandatory QR Code for Top 300 Domestic Brands (National API/Formulation Mandate) | Guide |
Saudi Food and Drug Authority • Kingdom of Saudi Arabia (KSA) & GCC
GCC & MENA Health Authorities • Middle East & North Africa (UAE MOHAP, Oman, Kuwait, Egypt EDA, Jordan JFDA)
ASEAN Health Authorities • Southeast Asia (NPRA Malaysia, BPOM Indonesia, FDA Philippines, HSA Singapore, TFDA Thailand, DAV Vietnam)
African Health Authorities & Harmonization • Sub-Saharan Africa (Tanzania TMDA, Nigeria NAFDAC, South Africa SAHPRA, Kenya PPB, Ghana FDA)
CIS & Eurasian Economic Union • Eurasia (Russia Minzdrav, Kazakhstan NCEKS, Uzbekistan GUSP, Belarus, Azerbaijan)
Central Drugs Standard Control Organisation • India (CDSCO & State Licensing Authorities / SLAs)
Stop Managing Global Authorizations on Disconnected Spreadsheets
Novaqis RIMS unifies country-by-country Marketing Authorizations, automated 180/90/30-day renewal warnings, and native packaging artwork proofing on a single validated 21 CFR Part 11 platform with $0 named-user seat taxes.