Sarah Koehler

Electronic Post Market Safety

Electronic Post Market Safety

The Food and Drug Administration (FDA) recently finalized the guidance for post-market safety reports of biologics and...

Initiation of Risk Assessments

Initiation of Risk Assessments

Risk Assessments are a powerful tool used to elevate regulatory decisions and product changes. Risk assessments are...

Principles of Data Integrity

Principles of Data Integrity

Data integrity is one of the most critical factors in any regulated industry. This is because any data error could...

Over-the-Counter Products

Over-the-Counter Products

Non-prescription drug products are classified as over-the-counter (OTC) drug products. OCT products are drugs that are...

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 quality,...

Medical Device PMA

Medical Device PMA

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

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...

Drug Quality Testing

Drug Quality Testing

The approval of new and generic drugs and biologics requires compliance with the Food and Drug Administration (FDA)...

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