Medical device association AdvaMed has hired Melissa Torres to replace Janet Trunzo as EVP of technology and regulatory affairs.

Key opportunities in the European medical devices market include leveraging comprehensive regulatory guides to streamline product registration across diverse countries, utilizing soft skills for ...

Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent ...

In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and clinical studies and managing chemistry, manufacturing, and controls (CMC) ...

Biotechnology is a complicated field—there are tons of rules in place to keep people safe. In this certificate, you will learn about the legal and ethical aspects of drugs, biologics, devices, and ...

RCRA’s mission continues to be ensuring that all the research conducted at Drexel University adheres to the highest ethical, legal, and regulatory standards, safeguarding the integrity of research and ...

Regulatory affairs professionals play a pivotal role in ensuring that pharmaceuticals, biologics, medical devices, and other life science products comply with all the relevant regulations. Their work ...

Much like achieving the ideal Philly cheesesteak, when developing a pharmaceutical or biologic specific process and related finished product, product specifications and characteristics must be clearly ...

Ever present but seldom seen, while being increasingly vital, the rapidly expanding area of the Chemistry, Manufacturing and Controls (CMC) of pharmaceutical products is gradually developing into a ...

Pharmaceutical companies operate in a highly regulated environment where every product must meet strict safety and effectiveness standards. Managing compliance and approvals is complex, so many firms ...