Blog Category: Standards

Regulatory Database, a Boon to the Manufacturers

Standards

Many Organizations are relaying on the Regulatory Intelligence databases due to burden of collecting, understanding, interpretation of data from the regular authorities. Regulatory Intelligence tools...

Business Compliance, DataSolutions, Regulatory Affairs, Regulatory Intelligence, Regulatory Updates

Regulatory Reporting Software – Challenges and Opportunities

Standards

The pharmaceutical manufacturing industry has been rapidly evolving. The manufacturers of drugs, vaccinations, and medical devices, among others, face numerous business challenges, which...

Automation, Compliance, Pharma Manufacturing, Pharmaceutical, Regulatory Reporting

AI-enabled and Human reviewed Regulatory Intelligence Tool

Digital Health

The creation, capture, and data consumption have increased by roughly 5000% in the last 12 years. As a result, businesses are finding that proper handling of that data involves far more processes than...

AI, Regulatory Compliance and Intelligence Tool, Regulatory Intelligence, Regulatory Monitoring, Regulatory Strategy

USA/Canada/UK/EU approved product Labels: Aug 2022

Standards

Below are some analytics and counts of Product labels released from Canada, USA, UK and EU. Following 5 charts give the breakdown of these A. Human prescription labels by Country: ...

Color Additive Petitions

Standards

FDA Recommendations for Submitting Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, and Medical Devices The Food and Drug Administration (FDA) provides guidance on...

MHRA Guidance on the use of Real-World Data in Clinical Studies to Support Regulatory Decisions

Standards

A large amount of data is continuously being gathered on patients through various sources such as electronic health records (EHR) and disease or patient registries. These data, referred to as Real...