February 4, 2021
It all starts with a game plan. Just like any Super Bowl contender starts with a game plan, anyone involved with drug development should too. A CMC game plan becomes your pathway to success.
April 1, 2021
There are many ways for companies to get approvals for expedited development. This is primarily based on trials and data from clinical studies. The biggest issue has always been how acceleration impacts CMC. In many cases, the data and the programs need time and cannot be expedited. So how do you ensure CMC doesn't become the bottleneck?
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.