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Case Studies
Biotechnology manufacturing is a complex and highly regulated field that demands precision, consistency, and ...
Good Clinical Practice (GCP) is an internationally recognized set of standards for the design, conduct, ...
In the highly regulated industries of pharmaceuticals, biotechnology, and medical devices, ensuring that systems ...
In the dynamic and ever-evolving field of drug development, the U.S. Food and Drug Administration (FDA) plays a ...
The Failure Mode and Effects Analysis (FMEA) tool allows an organization to examine the possible hazards and risks ...
Evolution is the process by which species change over time in response to environmental pressures. Often referred ...
When reporting an Adverse Event (AE) to the U.S. Food and Drug Administration (FDA), utilizing the FDA Adverse ...
A remote audit is a method of conducting an audit without the need for physical presence at the audited site. The ...
The 510(k) is a premarket submission made to the Food and Drug Administration (FDA) by medical device ...
You’ve gathered all your paperwork, submitted the right forms to the right authorities, set up your manufacturing ...
In the fast-paced and highly regulated world of life sciences and medical devices, compliance with regulatory ...
In the evolving landscape of global medical device regulation, the European Union In Vitro Diagnostic Regulation ...
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