Global harmonization of CMC guidelines is a key focus for top pharmaceutical consultants. Variations in regulatory requirements across regions often create inefficiencies in drug development—for ...

As we load up our cars for our annual holiday treks to visit friends and family across the country, many of us will also be loading our destinations into our phones and onboard navigation systems. I ...

A key part of consultants’ work is the global harmonization of CMC guidelines. Differences in regulatory requirements across regions can lead to inefficiencies in the drug development process.

Imagine your team is embarking on a new project. The product team hands over user stories and wireframes, neatly packaged, and everyone seems satisfied. The requirements appear clear enough; no one ...

The invention, rapid manufacturing and distribution of the COVID-19 vaccine demonstrates exactly how fast the life sciences treatment development pipeline can move when the right factors are in play.

The Fast Company Executive Board is a private, fee-based network of influential leaders, experts, executives, and entrepreneurs who share their insights with our audience. BY Kevin Bailey Artificial ...

Back in 2022, I wrote about the triple threat of additive, agility and automation—three forces that were already reshaping manufacturing and product development. Fast forward to 2025, and these trends ...

The term Secure Product Development Framework (SPDF) was introduced by FDA in the draft guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" ...

Product development (“PD”) is a core competency for any product-oriented company, whether a Fortune 100 firm, a small engineering business, or a technology-based startup. Commercializing innovative ...

The latest trends in software development from the Computer Weekly Application Developer Network. It would be unfair to criticise any firm for being quieter throughout the last three years of C-19 i.e ...