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 […]
Regulations
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
Veterinary Pharmaceuticals Regulations and Registration in Japan
Japan has a well-defined framework for veterinary medicines. For global regulatory teams and animal health companies, however, meeting the requirements
Managing Label Changes Under IVDR for IVD Manufacturers
Since IVDR came into effect, IVD manufacturers have had to respond to changes across clinical evidence, quality management, vigilance and
UK Cosmetics Regulatory Requirements & Registration Process
A separate UK compliance process now needs to be undertaken to sell cosmetics in Great Britain. Brands that only notify