Tag: Regulatory Updates

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

September 12, 2023
Biopharma

ASIA Pakistan Draft Format for Submission of Data under the Ethical Marketing to Healthcare Professionals Rules 2021 The Ethical Marketing to Healthcare Professionals Rules have been notified...

Asia Regulatory News, BioTech, ECTD Validation, Good Manufacturing Practice, Pharma, Post Marketing Surveillance, Regulatory Updates, ROW Regulatory News

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

July 26, 2023
Biopharma

ASIA Singapore Guidance on therapeutic product registration in Singapore This guidance document describes the procedures and requirements for submitting an application to register a therapeutic...

Asia Regulatory News, BioTech, New Molecular Entities, Pharma, Regulatory Updates, ROW Regulatory News, Swissmedic, Therapautic Product

Regulatory Intelligence shows path to the Success in Pharma Industry

July 21, 2023
Biopharma

Pharma companies need to be well-versed regarding regulatory intelligence while develop, manufacture and release products into the market. Companies have to analyze, monitor and gather the information...

Compliance, Healthcare, Medical Devices, Pharma Industry, Regulatory Intelligence, Regulatory Updates

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

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 – 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