AI Dossier Authoring Software for CTD & eCTD Submissions
Intelligent dossier construction, section by section, market by market. QuriousRI’s Dossier Authoring module transforms the way regulatory dossiers are built.
Regulations
Global RLD Intelligence (RLDi) – Approved Products Explorer
Reference Drug and Approved Products Assessment for Global Regulatory Strategy QuriousRI’s Global RLD Intelligence offers evidence-based assessment and intelligence to
Qurious RI DMF Database Module for Global DMF and CEP Status Tracking
Qurious RI’s DMF Database module offers a platform for tracking evidence-based, audit ready DMFs and CEPs status for APIs and
QuriousRI Nitrosamine Assessment Tool for Global Regulatory Compliance
QuriousRI’s Nitrosamine assessment tool is part of global regulatory strategy platform offering a single platform for evidence-based, audit-ready decision support
Certification of Suitability (CEP): Application Process & Sister CEP Submissions
A CEP stands for Certification of Suitability to the monographs of the European Pharmacopoeia. It is used for substances covered
eCTD Structure & Submission Process
The Electronic Common Technical Document (eCTD) is the standard electronic format used for many regulatory submissions involving drugs and biologics.
Food Packaging and Labelling Requirements in the UK
On September 4, 2026, the UK Food and Standards Agency released packaging and labelling guidance. It provides the legal requirements
Medical Device Regulations and Registration Process in Sweden
Sweden is an EU Member State. That means medical devices here fall under EU MDR (Regulation (EU) 2017/745) and IVDR
CDSCO Post-Approval Change Applications for Medical Devices
A CDSCO medical device licence is not a finish line. Manufacturing sites move, designs get refined, labels get updated, agents