Clinical Research Solutions
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
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
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
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
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
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
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
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
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
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...