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.

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. ...
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 ...
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 ...

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