Category: Biopharma

AI – Transformation of Regulatory Intelligence in Pharma

May 22, 2023
Biopharma

AI is transforming regulatory intelligence in pharma by providing faster and more accurate access to relevant information. Regulatory intelligence involves monitoring and analyzing regulatory changes...

AI, Artificial Intelligence, Natural Language Processing, NLP, Predictive Analytics, Regulatory Intelligence, Regulatory Reporting, Risk Assessment

Pharma/Biotech – USA, Europe Regulatory News, May 2023 Vol. 1

May 4, 2023
Biopharma

USA FDA Seeks Comments on Proposed Consumer Rx Advertising Survey The FDA Office of Prescription Drug Promotion (OPDP) is seeking input on its proposal to conduct research into how consumers...

Biotech Regulatory News, EU Regulatory News, European Medicines Agency, Pharma Regulatory News, Regulatory News, US FDA, USA Regulatory News

Pharma/Biotech – Asia, ROW Regulatory News, April 2023 Vol. 2

April 20, 2023
Biopharma

ASIA Malaysia Declaration of Worldwide Registration Status for Generic Medicines in QUEST System All new applications for Generic Medicines (Prescription-Full) shall declare...

ANVISA, Asia Regulatory News, BioTech, Chemistry, eCTD, Manufacturing and Control (CMC), Pharma, Regulatory Updates, ROW Regulatory News

Pharma/Biotech – USA, Europe Regulatory News, April 2023 Vol. 1

April 5, 2023
Biopharma

USA FDA Issues Guidance on ISO Data Standards for Medicinal Products As part of its efforts to harmonize with international standards for exchange of medicinal product data, the FDA has issued...

Biotech Regulatory News, EU Regulatory News, European Medicines Agency, Pharma Regulatory News, Regulatory News, US FDA, USA Regulatory News

Pharma/Biotech – Asia, ROW Regulatory News, March 2023 Vol. 2

March 21, 2023
Biopharma

Pakistan Pakistan’s DRAP encourages users to update pharmacovigilance app after recent revisions The Drug Regulatory Authority of Pakistan (DRAP) has asked users of its Med Safety App to update...

Maximizing Success and Mitigating Risk: The Strategic Role of Pharma Regulatory Intelligence Database in the Pharmaceutical Industry

March 14, 2023
Biopharma

Regulatory intelligence refers to the process of gathering and analyzing information about the regulatory landscape, including laws, policies, and guidelines, that may affect a particular industry....

Drug Development, Mitigating Risk, Pharma Regulatory Intelligence, Regulatory Affairs, Regulatory Intelligence, Regulatory Intelligence Database