Why is Grasping Data Security and Selecting Compliant Software Vital in the Realm of Regulatory Affairs?

In today's digital era, data security and compliance are more than just buzzwords-they are critical components of success for any organization, especially in sectors such as life sciences, pharmaceuticals, medical devices, and similar fields. Regulatory compliance is a complex landscape, and with the increasing reliance on software and technology, it becomes paramount to understand why data security and choosing compliant software are essential.

Throwback 2018 – The Regulatory Summary in a Nutshell

The life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way.

3 FDA’s Final Guidance Docs for Individual Patient Expanded Access - What should You Know?

Times when patients are going through serious / immediately life-threatening conditions and physicians are left with no options except to opt for the investigational treatments, navigating certain processes would be challenging and time-consuming. Reducing those procedural burdens to streamline the processes and in order to provide the physicians the flexibility to access investigational drugs and biologics, the US Food and Drug Administration (US FDA), on June 2, 2016 has released 3 final guidance documents.