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.
December 6, 2023
Supply chain management is fundamental to business success. The past few years have demonstrated the importance of robust supply chain processes, from the security of raw materials to the optimization of business processes to maximize operational efficiencies.
October 25, 2023
Many pharma and biotech startups may question the idea of whether a Project Manager is really useful; is it simply another layer to add to the complex array of personnel and job responsibilities? There are a number of tools available; most commonly recognized among these is the classic Gantt chart – so why add another person to the mix just to manage that?
