Tag: Regulatory Affairs

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

The Role of Regulatory Tracking Software in Accelerating Drug Approval Processes

September 22, 2023
Digital Health

In order to distribute the products, pharmaceutical manufacturers must ensure compliancy with global and local regulations and provide the required testing and reporting to validate products, their...

Compliance Solutions, Drug Approval, Drug Registration, Regulatory Affairs, Regulatory Management, Regulatory Tracking Software

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

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

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