June 3, 2021
FDA Meetings aren’t what many people think they are especially when it comes to the CMC-focused discussions. We look at seven common opinions about formal meetings between the FDA and Sponsors or Applicants of PDUFA Products when it comes to CMC compliance and compare them to reality.
April 15, 2021
Learn how to guide sponsors in the critical exercise of materials characterization and the establishment of reference standards for NCEs as well as in the formulation of drug products from the IND-enabling stages of development through postapproval evergreening changes.
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?
March 18, 2021
DS InPharmatics' Senior Drug Substance Consultant, James Mencel, provides us with insight on his background with CMC management and the impact that expedited drug development programs have had on the pharma industry. Learn how to break down regulations, breakthrough designations, and the best practices suitable when it comes to these programs.
March 4, 2021
With comprehensive, integrated CMC Regulatory Strategy, emerging sponsors gain greater insight into their Drug Development programs, avoiding bottlenecks and mitigating risks before they lead to mistakes and costly delays. Boost your compliance performance across the complete lifecycle. Ensure consistency and quality in every transaction.
February 11, 2021
What daring goals did you set in 2020? Did you reach them? 2021 is a New Year. Your year to get clear on where you're going and how to get there.
