Clinical Research Solutions
European Marketing Authorization Success: The Critical Role of Quality and Compliance
Entering the European market isn't just about gaining marketing authorization — it's about sustaining it. For life sciences companies, success hinges on a robust approach to quality and compliance,...
Clinical Research Solutions
Pros and Cons of Working with a CRO
A Contract Research Organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract...
Clinical Research Solutions
Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guide for Marketing Authorization Holders (MAHs)
In today’s stringent regulatory landscape, the effectiveness of a pharmaceutical company’s pharmacovigilance (PV) system is supported by three key pillars: the Qualified Person for Pharmacovigilance...
Clinical Research Solutions
Mastering Clinical Trial Submissions in Europe: A Guide for Drug Developers
Launching a clinical trial in Europe is a complex but rewarding endeavor, requiring careful navigation of regulatory frameworks, ethical requirements, and submission processes. Recent regulatory...
Clinical Research Solutions
FMEA Is Not a Crystal Ball: Why You're Missing Critical Risks in Medical Device Lifecycle Management
Imagine trying to predict how a medical device could cause harm—but you're only allowed to look at one failure at a time, with no context, interactions, or real-world complexity. It's like peering...
Clinical Research Solutions
CMC Expectations During Drug Substance Transfer from Ex-US Manufacturers
Regulatory Drivers for US-based API Manufacturers Recent shifts in US tariff policies have introduced new pressure points in the global pharmaceutical supply chain, particularly for manufacturers...
Clinical Research Solutions
FDA Audit Preparation 101: How to Prepare and Manage an FDA Inspection
Imagine for a moment that this is your current situation… You receive a frantic call from the receptionist at your facility. An Investigator1 from the Food and Drug Administration (FDA) has just...
Clinical Research Solutions
Advancing Digital Transformation in Medicines: EMA's Successful ePI Pilot
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have recently concluded a successful pilot project on electronic product information (ePI), marking a significant...
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...
Clinical Research Solutions
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...
Clinical Research Solutions
15 Days of Panic Revisited: You Received an FDA Form or 483 Form 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...
Clinical Research Solutions
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...