Blogs

March 14, 2025
Published by Meranda Parascandola at March 14, 2025

A complete guide to CMC regulatory affairs services

Bringing a new drug to market requires more than just scientific innovation. It demands rigorous quality control, reliable manufacturing, and strict adherence to global regulatory standards. Agencies such as the FDA, EMA, MHRA, and PMDA impose Chemistry, Manufacturing, and Controls (CMC) requirements to ensure pharmaceutical products remain safe, effective, and […]
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March 28, 2025
Published by Meranda Parascandola at March 28, 2025

Do You Need cGMP Quality Compliance Consulting Services?

Navigating the complexities of regulations in pharmaceuticals, biotechnology, or medical devices demands precision and expertise. Current Good Manufacturing Practices (cGMP) compliance isn’t optional—it drives business success and safeguards public trust. cGMP quality compliance consulting transforms these challenges into opportunities by crafting targeted strategies and delivering actionable guidance to ensure your […]
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April 4, 2025
Published by Meranda Parascandola at April 4, 2025

FDA INTERACT Meetings: What You Need to Know

For early-stage drug developers, engaging with the FDA at the right time can be critical to success. One such opportunity is the INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) meeting. This meeting provides early-stage guidance from the FDA’s Center for Biologics Evaluation and Research (CBER) and Center […]
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April 4, 2025
Published by Meranda Parascandola at April 4, 2025

What is a Pre-NDA Meeting?

The path to FDA drug approval involves several critical milestones, one of the most important being the Pre-New Drug Application (Pre-NDA) meeting. This crucial step provides pharmaceutical companies with an opportunity to engage with the FDA before submitting a New Drug Application (NDA). Understanding the significance of a Pre-NDA meeting […]
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April 4, 2025
Published by Meranda Parascandola at April 4, 2025

Why PDUFA VII User Fees Are on the Rise in 2025

The Prescription Drug User Fee Act (PDUFA) has been a cornerstone of the U.S. Food and Drug Administration’s (FDA) drug approval process since its inception in 1992. With the implementation of PDUFA VII (2023-2027), user fees for FY 2025 have been published, reflecting a notable increase that will impact pharmaceutical […]
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April 4, 2025
Published by Meranda Parascandola at April 4, 2025

How to Exercise FDA Inspection Readiness

FDA inspections are a critical aspect of regulatory compliance for pharmaceutical, biotech, and medical device companies. A well-prepared organization can navigate inspections smoothly, avoid compliance violations, and maintain operational efficiency. This article outlines the key steps companies should take to ensure FDA inspection readiness. Understanding FDA Inspections The U.S. Food […]
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