Resource Center

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.

Types of Combination Products

Types of Combination Products

A combination product is a product composed of two or more regulated components. Examples of combination products ...
Unapproved Drugs

Unapproved Drugs

Unapproved prescription drugs propose a significant risk for patients since they haven’t been reviewed for ...
Medical Device PMA

Medical Device PMA

In 1976, the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Acts established three regulatory ...
Types of Regulatory Audits

Types of Regulatory Audits

There are many different types of Regulatory audits that can be conducted. These are audits that upon successful ...
Certificate of Analysis

Certificate of Analysis

A certificate of analysis (CoA) is a document that manufacturers create that verifies the products they ...
When to Pursue Quality

When to Pursue Quality

Quality is something that should be integrated into an organization. To pursue quality means to drive forward ...
EU Technical Files

EU Technical Files

A concept similar to the FDA’s Design History Files, the EU Technical File is a collection of documents related to ...
Product Testing of Cosmetics

Product Testing of Cosmetics

Cosmetics are a separate category under the Food and Drug Administration (FDA) different from medical devices or ...

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