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An internal audit program is vital for proper monitoring and assurance of products. It is also ...
A Design History File, DHF, is part of the requirements set by the FDA and other regulatory bodies for ...
During the early stages of a drug’s preclinical development, after a product is identified as a viable ...
As more and more states legalize the use of medicinal and recreational marijuana, and as more consumer ...
One of the critical choices for staying on the premarket notification, the 510(k) pathway, is choosing ...
Audits can be a stressful time for a company. Even if it is known in advance when the audit will occur ...
Contract Manufacturing Organizations, CMOs, have become commonplace in the life sciences industry. ...
The FDA conducts Pre-Approval Inspections (PAI) to assure that a facility can manufacture the intended ...
The FDA defines validation as a process required to establish documented evidence that provides a high ...
Claims are defined statements, symbols, or wording that are made on a product. They can be advertising, ...
Providing a quality product while meeting all quality standards set by regulatory bodies can often prove to be a ...
With the implementation of the new Medical Device Regulation (MDR) 2017/745 in the European Union, a ...
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