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One of the more ambiguous parts of the Quality System Regulations, 21 CFR 820, is making judgments ...
Registering a new device with the FDA can be tricky. The first step is to choose what pathway to follow ...
A Quality Management System (QMS) is often designed well before a company starts the development of its ...
For most of the major sections of the life sciences industry, a proper Quality Management System (QMS) ...
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 ...
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