Laboratories, whether clinical or non-clinical, have to follow certain Good Laboratory Practices (GLP). Nonclinical...
Quality Systems
Reporting Timelines for Adverse Events
When an event occurs related to a medical device there is the need to determine if it qualifies as an adverse event...
Medical Device PMA
In 1976, the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Acts established three regulatory...
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
A certificate of analysis (CoA) is a document that manufacturers create that verifies the products they manufacture...
When to Pursue Quality
Quality is something that should be integrated into an organization. To pursue quality means to drive forward...
Accelerated Stability Testing
Accelerated stability testing increases the rate of chemical degradation and physical change of a drug by using...
Medical Device Single Audit Program
In 2016 the Medical Device Single Audit Program (MDSAP) was initiated. Having a global approach to monitoring and...
EU Technical Files
A concept similar to the FDA’s Design History Files, the EU Technical File is a collection of documents related to the...
Product Testing of Cosmetics
Cosmetics are a separate category under the Food and Drug Administration (FDA) different from medical devices or...
Pharmaceutical QMS
A quality management system, QMS, is a crucial requirement for any organization in the life sciences industry....
Aseptic Technique
Aseptic technique is the practice and procedures utilized to prevent contamination from pathogens. There are four main...
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