During the early stages of a drug’s preclinical development, after a product is identified as a viable...
Alexis Ferrier
Choosing a Predicate Device
One of the critical choices for staying on the premarket notification, the 510(k) pathway, is choosing the...
Preparing for a Pre-Approval Inspection
The FDA conducts Pre-Approval Inspections (PAI) to assure that a facility can manufacture the intended product...
The Value of Validation in a QMS
The FDA defines validation as a process required to establish documented evidence that provides a high degree...
Understanding Label Claims
Claims are defined statements, symbols, or wording that are made on a product. They can be advertising,...
Determining the Right Regulatory Pathway for your Drug
A fundamental question in any drug development program is which regulatory pathway to pursue. There are...
Process Validation Differences Between Pharma and Medical Devices
Process Validation is a formal methodology that companies utilize to manufacture products with a defined...
Why More Companies Should Participate in VCRP
The FDA regulates a wide range of manufactured goods for consumers, including food, electronics, medications,...
The Role of CMO’s in Life Sciences Manufacturing
Navigating ever-changing markets and supply chains has been challenging for many companies in the ongoing...
Importance of Document Control on a Quality Management System
In highly regulated industries, document control is among the most necessary means for compliance. A document...
Differences Between ISO 13485:2016 and 21 CFR 820
Regulations ensure medical device manufacturers produce consistent safe products. A well-structured...
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