COmpliance

Innovations in Gendered Heart Disease Research

Innovations in Gendered Heart Disease Research

Heart disease is the leading cause of death in the United States equally impacting all. Being Women’s Health Week, we want to highlight the impact heart disease has on the livelihood of women and what new developments there are in the life sciences innovation world that would reduce the impact it has on society.

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...

Particulates in Final Product

Particulates in Final Product

Visual inspections ensure that visible particulates are not present in products manufactured by an organization....

RO Water System

RO Water System

In pharmaceutical manufacturing, there is the need to use sterile water in production and cleaning activities. This...

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,...

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