Tag: Regulatory Affairs

Medical Devices – USA, Europe, Asia and ROW Regulatory News – May 2025

June 4, 2025
Medical Device

USA Guidance Document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program The aim of this guidance document is to outline the various mechanisms available...

Compliance, Digital Health, EU Regulations, FDA, Global Health, Healthcare Innovation, Med Tech, Medical Devices, Regulatory Affairs, UDI

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Mar 2025

April 8, 2025
Medical Device

USA Evaluation of Sex-Specific Data in Medical Device Clinical Studies – Guidance for Industry and Food and Drug Administration Staff This guidance document, issued by the FDA, focuses...

EU Regulations, Global Med Tech, Healthcare Compliance, MDR Update, Med Tech News, Medical Device News, Medical Device Regulations, Medical Devices 2025, Regulatory Affairs, Regulatory Update

Regulatory Intelligence Database, Software & Tools for Compliance

March 19, 2025
Regulatory Intelligence

What is Regulatory Intelligence? Regulatory Intelligence (RI) is the process of collecting, analysing, and interpreting regulatory information to help organizations comply with legal and industry...

Compliance Software, Medical Device Regulations, Pharma Compliance, Reg Tech, Regulatory Affairs, Regulatory Compliance, Regulatory Intelligence, Regulatory Technology, Regulatory Updates

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Feb 2025

March 11, 2025
Biopharma

USA FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes The U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog...

Asia Biotech, Biotech 2025, Biotech Insights, Biotech Updates, Europe Pharma, Pharma News, Pharma Regulations, Pharma Trends, Regulatory Affairs, ROW Regulatory, USA Regulations

Medical Devices – USA, Europe, Asia and ROW Regulatory News – Jan 2025

February 6, 2025
Medical Device

USA Guidance on Premarket Approval Application and Humanitarian Device Exemption Modular Review The guidance provides information on the Premarket Approval Application (PMA) and Humanitarian...

Device Approval, EU Regulations, FDA, Global Regulations, Healthcare Regulations, Innovation Healthcare, MDR2025, Medical Device, Medical Device Compliance, Medical Device Industry, Regulatory Affairs, Regulatory News, Regulatory Updates

Navigating Cosmetic Regulations: Guide to Compliance with Global Standards

September 30, 2024
Cosmetics

In today’s rapidly evolving beauty and personal care market, understanding the global landscape of cosmetic regulations is more critical than ever. With consumers increasingly aware of what goes into...

Beauty Industry, Beauty Products, Cosmetic Brands, Cosmetic Compliance, Cosmetic Innovation, Cosmetic Regulations, Cosmetic Standards, Cosmetic Testing, Global Compliance, Ingredient Transparency, Product Safety, Regulatory Affairs