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 […]
January 2, 2024
Biotechnology firms are cropping up all over the place, and growing at an unbelievable rate. California alone is home to over 3,000 life sciences companies, employing over 287,000 people[1] and the global industry is expected to be worth $727.1 billion by 2025.[2]
December 12, 2023
There are no holidays or time off when it comes to complying with regulations. Companies always need to be ready to meet the latest standards. With that in mind, new FDA programs are sure to keep pharmaceutical companies of all sizes busy in the year ahead. Here’s how to get through.
