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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

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

Medical Devices-Asia and ROW Regulatory News – April 2023

April 18, 2023
Medical Device

ASIA INDIA (CDSCO) Circular for Licensing of Class C & D medical devices According to the Circular It is pertinent to mention that as per Medical Devices rules (MDR) 2017 manufacturing...

Asia Regulatory News, Medical Devices, Regulatory News, ROW Regulatory News, SaMD, Software as a Medical Device

MDR Regulations – Impact on Medical Devices

April 18, 2023
Medical Device

The EU Medical Device Regulation (MDR) has been in effect since May 26, 2021 and has had a significant impact on the global medical device industry. Below mentioned are the 7 ways the...

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

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