April 11, 2024
Mastering the Art of Controlled Release: A Journey Through Drug Formulation Complexities.An Interview with Kyriakos Michailaros Could you introduce yourself and your expertise in drug development and manufacturing? Following on from my university studies, my career has centered around the development and production of pharmaceuticals. Upon earning my degree in […]
March 22, 2024
The FDA Fast Track and Accelerated Approval pathways can expedite the review of new drugs. It is important to understand these pathways and how they impact drug development, as well as other industries, like healthcare and pharmaceutics. FDA Fast Track Designation: Accelerating The Time During The Drug Development Process The […]
March 14, 2024
In this interview, NewsMed spoke with Joseph P. Ivan regarding the Comprehensive Assessment and Management Approach to Optimizing Pharmaceutical Supply Chains. How do you optimize supply chain strategies while navigating the complexities of international regulation guidelines? Navigating international regulations demands the employment of diverse strategies. While consolidating supplies into a […]
February 9, 2024
In the realm of pharmaceuticals, data integrity stands as a cornerstone, underpinning the veracity of scientific research, the efficacy of drug development, and the safety of patient outcomes. This critical facet of pharmaceutical quality assurance has evolved significantly, particularly in the wake of advancing technology and stringent regulatory standards. Our […]
January 17, 2024
Introduction U.S. companies face unique challenges and opportunities in the global race to develop and market new pharmaceuticals. A critical step in this journey is navigating the European Medicines Agency's (EMA) regulatory framework for Investigational Medicinal Product Dossier (IMPD) applications and Marketing Authorization Applications (MAAs). Understanding these processes is key […]
January 16, 2024
The pharmaceutical industry is growing through global collaboration and market expansion. To continue this growth, regulatory compliance for Chemistry, Manufacturing and Controls (CMC) must be followed. Without CMC regulatory compliance, the safety behind the creation of any products could be compromised. CMC regulatory compliance is a topic that DS Inpharmatics […]
