The Life Science industry and regulatory profession have a plethora of acronyms and technical terms. Our glossary aims to help make sense of these. Search by clicking on the letters above.
Latest definitions
Project Management Plan
The purpose of this document is to define the scope of activities, outline responsibilities (define task and roles) and provide…
Pre-Sub Meeting
FDA Pre-Sub meetings are available for manufacturers to obtain regulatory feedback on various medical device applications in the US in…
Pre-Market Notification (510(k))
The US Food and Drug Administration (FDA) requires a 510(k) for moderate-risk Class II medical devices. A 510(k) is also…
Pre-Market Approval (PMA)
The US Food and Drug Administration FDA requires Premarket Approval PMA for high-risk class III medical devices where no identifiable…
Post-Authorization Safety Study (PASS)
A Post-Authorization Safety Study (PASS) is a study performed after the marketing authorization and aiming principally to further evaluate the…
Post-Authorization Efficacy Study (PAES)
A Post-Authorization Efficacy Study (PAES) is a study performed after the marketing authorization and aiming principally to further evaluate the…
Pharmacovigilance System Master File (PSMF)
A Pharmacovigilance System Master File is a document describing the pharmacovigilance system used by the marketing authorisation holder (MAH) with…
Pharmaceutical Establishment License (PEL)
Whilst marketing approval is granted for a given product, the company applying for marketing license may also be subject to…