The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

When pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

Successful risk management is essential to the design and development of safe and effective medical devices. Unfortunately, it is too often viewed by manufacturers as an isolated activity that must be ...