October 20, 2022
Biologics are complex molecular entities that require extensive planning and development strategies to control development costs, ensure compliance with regulations, and speed up a product to commercialization. Hiring a biologics consultant ensures you receive expert advice and support throughout the entire CMC development process. In this article, we will outline why you should consider a biologics consulting service and what benefits this will have for your company.
October 14, 2022
An Investigational Device Exemption (IDE) is an application submitted to FDA to obtain their approval to use your novel medical device in a clinical study in order to obtain safety and effectiveness data to support a full market approval. There are several types of studies: early feasibility (i.e., a study […]
October 13, 2022
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.
August 30, 2022
The pharmaceutical supply chain is a complex network of processes that must work together to ensure patients receive vital medicines promptly and safely. Supply chains can be challenging, but managing them well is the key to successful pharmaceutical business.
August 8, 2022
You have heard the phrase “time is money.” No other statement can be more accurate for the medical device industry than this one. Every day you are not approved to market your device is a day of lost revenue. But unfortunately, it is also a day that patients don’t get […]
August 3, 2022
CMC information reinforces the connection between the quality of a candidate drug used in clinical studies and the end product marketed to consumers. It effectively outlines critical quality attributes across the full life cycle of drug products, from clinical development to commercial scale production. Like current good manufacturing practices (cGMP, or GMP), CMC reviews have regulatory requirements established by the US FDA. But where the goals of these two pharmaceutical control strategies are closely aligned, they differ significantly in approach and regulation.