Blog Category: Standards

Regulatory Database, a Boon to the Manufacturers

June 27, 2023
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

April 27, 2023
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

April 5, 2023
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

September 27, 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

September 24, 2022
Standards

FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices Food and Drug Administration (FDA) provides guidance for the...

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

January 7, 2022
Standards

There are vast amounts of data being collected on patients, for example, in electronic health records (EHR), and disease and patient registries. Such data are commonly called Real World Data (RWD),...