Resource Center
Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.
Sort by topic
Sort by resource type
The 510k program is by far the most popular medical device pathway, and as MedTech has continued to modernize and ...
In the USA, gene therapy products are regulated as biological products by the FDA’s Center for Biologics ...
The Food and Drug Administration (FDA) better protects the public health by aiding the food supply's safety and ...
The Food and Drug Administration (FDA) better protects the public health by aiding the food supply's safety and ...
As of May 2023, the FDA released an updated draft to the decentralization of trials for drugs, biologic products, ...
Ever since FSMA was signed into law in 2011, there hasn’t been another major reform for food safety; the HFP is ...
Most people are familiar with, or have at least heard of, the Health Insurance Portability and Accountability Act ...
This blog will review a brief history of substances that are Generally Recognized As Safe under FDA food regulations.
Supply chain issues are occurring all around the country which includes drug shortages. Drug shortages are ...
The Food and Drug Administration (FDA) is composed of six major centers. Each of these six centers are specialists ...
ISO 9001 is the international standard that specifies requirements for a quality management system (QMS) and is ...
“Perceptions are shaped by past experiences, culture, attitude, values, upbringing, and more. Once you have formed ...
Ready to learn more about working with us?
