Category: Standards

ANVISA Updates Importation Law: Key Changes

November 8, 2023
Standards

The introduction of RDC 751/2022 was significant for the Medical Device industry because it revised Brazil’s regulatory framework after two decades of validity. Despite the controversy surrounding...

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

Regulatory reporting software

January 31, 2023
Standards

Regulatory reporting software helps in collecting data from systems of companies and produces regulatory reports by industry regulations. A regulatory reporting system helps in managing and automating...

Artificial Intelligence, Case Safety Reports, clinical research, health authority documents, manufacturing, quality, R&D, Regulatory Reporting, Regulatory reporting software, regulatory reports, Safety reports

Global Regulatory Intelligence

December 13, 2022
Standards

The health authority (HA) guidelines, policies, and laws governing the product registration, manufacturing, or licensing processes keep evolving and vary across markets. Establishing an effective regulatory...

Clinical Trials, Compliance Procedures, Health Authority, Manufacturing Requirements, Regulatory Intelligence

Vistaar Regulatory Intelligence

December 2, 2022
Standards

VISTAAR provides Global regulatory submission requirements, guidance documents, updates, news and other regulatory details to Biopharma, Medical Devices, Digital Health, Diagnostics, Consumer Health...