FDA Guidance Documents on Digital Health: What You Need to Know

by PRP Consulting Team on Dec 5, 2024 1:39:46 PM

Digital health is transforming patient care, diagnostics, and treatment through innovations like mobile health apps, software as a medical device...

GUDID Data Trends in 2024: Key Insights for the Medical Device Industry

by PRP Consulting Team on Dec 3, 2024 7:11:26 PM

The Global Unique Device Identification Database (GUDID) has become a cornerstone of regulatory compliance and supply chain transparency in the...

Understanding the BsUFA III Regulatory Science Pilot Program

by PRP Consulting Team on Dec 3, 2024 7:04:37 PM

The Biosimilar User Fee Act (BsUFA) has been a key factor in expediting biosimilar approvals and enhancing regulatory efficiency in the U.S. Under...

FDA Final Guidance: Submissions for PCCP in AI-Enabled Device Software

by PRP Consulting Team on Dec 3, 2024 6:55:57 PM

The FDA's release of the final guidance on marketing submission recommendations for Predetermined Change Control Plans (PCCPs) in AI-enabled device...

Top 5 Keys to Success for Life Science Companies in 2025 and Beyond

by PRP Consulting Team on Nov 25, 2024 12:35:00 PM

The life sciences industry is entering a new era, shaped by rapid advancements in technology, evolving regulatory landscapes, and growing societal...

The Most In-Demand Jobs for Regulatory & Quality Compliance in Life Sciences: 2025 and Beyond

by PRP Consulting Team on Nov 25, 2024 12:27:25 PM

The life sciences industry is evolving rapidly, driven by advances in technology, the globalization of markets, and increasingly complex regulatory...

The Indispensable Role of People: What AI Cannot Do in Regulatory and Quality Compliance in Life Sciences

by PRP Consulting Team on Nov 25, 2024 12:16:02 PM

Artificial Intelligence (AI) has become a transformative tool in the life sciences industry, revolutionizing how Regulatory and Quality Compliance...