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GLP Booklet
The various acts enforced by FDA require an adequate showing of product safety prior to introduction into the marketplace. In order to ensure adequate...
BLA Booklet
The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate comm...
PMA 510k Booklet
Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. PMA regulates most Class III medical device. A PM...
ICH Q10 Guidebook
The ICH Q10 - Pharmaceutical Quality System is a harmonized Guideline in USA, Europe and Japan and was approved in 2008. This Guideline applies to pha...
GCP Booklet
Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critic...
ICH Q7 Guidebook
The ICH Q7 Guide "GMP for APIs" (formerly known as ICH Q7A) is a harmonized Guideline in USA, Europe and Japan and was approved in 2000. The guideline...
QSR Booklet
Medical Device Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements an...