CTD & ACTD Module Structure Explorer
Novaqis CTD/ACTD Structure Explorer is an authoritative dossier reference for Regulatory Affairs (RA) Directors and merchant pharma exporters. It maps ICH eCTD Modules 1–5 alongside ASEAN ACTD Parts I–IV, outlining mandatory documentation attachments, common health authority deficiency triggers, and the architectural bridge between SmPC updates and packaging dielines.
Regional Administrative & Prescribing Information
Region-specific legal, regulatory, and labeling documentation. Not harmonized by ICH; tailored to national health authority guidelines.
Mandatory Documentation Deliverables
- 1.GMP Inspection Certificate / WHO Certificate of Pharmaceutical Product (CPP)
- 2.Manufacturing License & Loan-License Agreement (if virtual pharma/merchant)
- 3.SmPC (Summary of Product Characteristics) & Package Leaflet (PIL)
- 4.Primary, secondary, and shipper packaging mock-ups / dielines
- 5.Legalized Price Certificate (SFDA, Egypt EDA, GCC)
Common Agency Deficiency Objections (Audit Defense)
- ⚠️SmPC dosage instructions out of sync with carton label text
- ⚠️Missing legalized consular apostille on CPP for GCC submissions
- ⚠️Non-compliant barcode symbology (e.g., missing SFDA Tatmeen DataMatrix)
Novaqis links regulatory dossier requirements directly to batch release records and prepress artwork dielines, enforcing cryptographic change control gates and eliminating costly agency deficiency cycles.
Unify Dossier Modules, MA Renewals, and Artwork on One Stack
Replace disconnected spreadsheets and rigid legacy enterprise systems. Novaqis RIM tracks marketing authorizations across 40+ countries, manages CTD/ACTD submissions, and automatically alerts your team 180, 90, and 30 days prior to registration expiry.