Newsletter | February 8, 2021

02.08.21 -- Regulatory Process Planning For Oral Solid Drug Development

 
The Importance Of End-To-End Thinking During Drug Product Development
 
Throughout a drug product development program, it is important to build robustness and flexibility into the manufacturing process. In this article, Dr. Kashif Ghaffar, process validation pharmacist, discusses what needs to be considered during product development in preparation for commercial manufacture.
Technical Considerations For Developing Oral Solids (Part 1)
 

Navigating your oral solids project from development through commercial manufacture can be a challenging path. This first installment in a two-part series examines the importance of technical groundwork and understanding excipients in the early stages of an oral solid's development project.

Oral Solid Dose Regulatory Hurdles And How To Approach Them
 
In your quest to meet the regulatory requirements for your oral solid project you may encounter significant hurdles. Anticipating these early on and thoroughly planning your approach can help. In this article experts discuss common regulatory challenges and how to approach them.
Solutions