Clinical Research Solutions
Maximizing the Value of FDA Pre-IND Meetings for Successful 505(b)(2) NDA Submissions
For drug developers leveraging the 505(b)(2) pathway, the FDA Pre-Investigational New Drug (Pre-IND) meeting is a strategic opportunity that can shape the trajectory of an entire development program....
Clinical Research Solutions
The Joint Commission Adds Pharmacists to Survey Teams: A Step Towards Comprehensive Healthcare Quality
In recent years, healthcare has undergone rapid transformation, especially in how care is delivered, measured, and improved. One of the most significant players in ensuring quality healthcare...
Clinical Research Solutions
FDA's Commissioner’s National Priority Voucher (CNPV) Pilot Program Overview
An inside look at FDA's new Commissioner's National Priority Voucher (CNPV) pilot program—what it is, why it matters, and how regulatory and development teams can leverage it to accelerate...
Clinical Research Solutions
Navigating FDA's Q-Submission Process: A Strategic Advantage for Medical Device Developers
In the highly regulated medical device industry, navigating FDA's submission process can be daunting, especially for start-ups. However, FDA's Q-Submission (Q-Sub) program offers a valuable...
Medical Information
From Discovery to Discontinuation: How Medical Information Supports Every Stage
The journey from compound discovery to market-ready pharmaceutical product is long, complex, and resource-intensive. Only about 1 in 5,000 drug candidates make it to patients1, underscoring the need...
Quality & Compliance
15 Days of Panic Revisited: You Received an FDA Form or 483 Warning Letter, Now What?
Remember the last time you were pulled over by law enforcement? Maybe it was for a broken taillight or driving a few miles over the speed limit. Even if you believed you hadn't done anything wrong,...
Clinical Research Solutions
Expanding into Europe? Accelerate Your European Marketing Authorization
For non-European pharmaceutical companies, expanding into the European market is both an exciting opportunity and a formidable challenge. While the potential for growth is significant, so too are the...
Medical Information
Navigating the German Pharmaceutical Landscape: Part Two
Market Access, Pricing, and Additional Compliance Considerations In part one, we explored the German pharmaceutical market and regulatory compliance requirements. Now, in part two, we will focus on...
Medical Information
How Multilingual Medical Information Services Enhanced Patient Safety During the COVID-19 Pandemic
The COVID-19 pandemic challenged nearly every aspect of healthcare delivery—and medical information (MI) services were no exception. As patients and healthcare professionals (HCPs) urgently sought...
Quality & Compliance
Navigating the German Pharmaceutical Landscape: Part One
Regulatory Considerations and Market Entry Germany is home to one of the most advanced healthcare systems in the world, making it an attractive but complex market for pharmaceutical companies. A...