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.
Sort by topic
Sort by resource type
Data integrity is one of the most critical factors in any regulated industry. This is because any data error could ...
Visual inspections ensure that visible particulates are not present in products manufactured by an organization. ...
In pharmaceutical manufacturing, there is the need to use sterile water in production and cleaning activities. ...
Non-prescription drug products are classified as over-the-counter (OTC) drug products. OCT products are drugs that ...
A combination product is a product composed of two or more regulated components. Examples of combination products ...
Unapproved prescription drugs propose a significant risk for patients since they haven’t been reviewed for ...
Laboratories, whether clinical or non-clinical, have to follow certain Good Laboratory Practices (GLP). ...
When an event occurs related to a medical device there is the need to determine if it qualifies as an adverse ...
In 1976, the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Acts established three regulatory ...
There are many different types of Regulatory audits that can be conducted. These are audits that upon successful ...
A certificate of analysis (CoA) is a document that manufacturers create that verifies the products they ...
Quality is something that should be integrated into an organization. To pursue quality means to drive forward ...
Ready to learn more about working with us?
