Category: Biopharma

What Pharma Companies need to know about EU MDR Regulations?

July 6, 2023
Biopharma

EU MDR The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices The EU MDR entered into application on 26 May 2021 REGULATION...

Compliance, EU MDR, Medical Device Regulations, Pharmaceutical Industry, Regulatory Affairs

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

June 21, 2023
Biopharma

ASIA India India starts mandatory tests of exported cough syrups after child deaths India will require manufacturers of cough syrups to acquire a Certificate of Analysis (CoA) from a designated...

Asia Regulatory News, BioTech, Pharma, Regulatory Updates, ROW Regulatory News

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

June 6, 2023
Biopharma

USA FDA Issues Development Program Guidance’s to Assist Drug, Device Sponsors The FDA published multiple guidance’s on Friday to help sponsors conduct drug-drug interaction studies...

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

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