Insights to improve drug submission success
While globalization has led to many new opportunities for developers of lifesaving medicines, it has also created new challenges when it comes to determining the many regulations that must be followed in order to successfully launch products into new markets.
On top of the many differences from country to country, the regulatory landscape is constantly evolving, which forces many drug developers to implement costly and time-consuming processes in order to track the countries in which they currently market their products as well as any countries targeted for expansion.
This is especially an issue when it comes to planning the chemistry, manufacturing and controls (CMC) module of an investigational or a new drug submission, as manufacturers must precisely meet the requirements from different health authorities or they run the risk of having their drug submission rejected.
Download the full report to learn more about the resources CMC professionals now have to increase their submission approvals.