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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.
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A Quality Management System (QMS) is often designed well before a company starts the development of its ...
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For most of the major sections of the life sciences industry, a proper Quality Management System (QMS) ...
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An internal audit program is vital for proper monitoring and assurance of products. It is also ...
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A Design History File, DHF, is part of the requirements set by the FDA and other regulatory bodies for ...
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During the early stages of a drug’s preclinical development, after a product is identified as a viable ...
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As more and more states legalize the use of medicinal and recreational marijuana, and as more consumer ...
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One of the critical choices for staying on the premarket notification, the 510(k) pathway, is choosing ...
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Audits can be a stressful time for a company. Even if it is known in advance when the audit will occur ...
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Contract Manufacturing Organizations, CMOs, have become commonplace in the life sciences industry. ...
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The FDA conducts Pre-Approval Inspections (PAI) to assure that a facility can manufacture the intended ...
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The FDA defines validation as a process required to establish documented evidence that provides a high ...
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Claims are defined statements, symbols, or wording that are made on a product. They can be advertising, ...
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