Knowledge Management

Knowledge Management (KM): Is the industry ready for it?

The most recent publication of ISPE Good Practice Guide on Knowledge Management (KM) brought once more to the attention the need to have the best practices established when it comes to KM Framework implementation.  In this blog post, we’ll go through some concepts on Knowledge Management.  So, if this is a topic of interest to you, stay with us!  Let’s start with a Read more…

Retrospective QbD

Developing a Retrospective QbD: a 4TE Story

Who doesn’t like a good story? Well, we have another for you! This time, we want to tell you how we helped a company in the Post-Approval Change Management of a Legacy Product using a Retrospective QbD methodology. Are you curious about it? Let’s check this out.   Let’s know what happened!  The company in our story faced some issues in managing the Post-Approval Read more…

QbD Framework

Accelerate time-to-market of a product using a QbD Framework: A 4TE Story

It’s 4TE story time! Today, we’ll talk about how we helped a company in accelerating the time-to-market of a drug product using a Quality by Design (QbD) framework.  As usual, our characters are confidential, but we are sure that we’ll be able to give you all the key insights about it. Are you ready to go on an adventure? Let’s go!   A Read more…