Every time software that pharma, medical device and biotech companies use for development and manufacturing gets updated, the FDA requires it to be validated for data integrity, reliability, and ...

Process validation plays a critical role in the success for a new biopharmaceutical on the path of commercialization, including the crucial process characterization. As a program advances towards ...

It has been a decent year for the biotech industry so far, buoyed by new drug approvals and positive regulatory/pipeline updates. The third-quarter earnings season has just kicked off, with most major ...