GMP

February 4, 2021
Super Bowl

What the Super Bowl Can Teach Us about CMC Strategy

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

Establishing Regulatory Starting Materials & Understanding the ICH

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?