QSR Bookpad
Medical Device Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements an...
Quality and Invention
GMP Bookpad
Since 1962 Amendment, US Congress instructed the FDA to require that all drugs be produced according to Good Manufacturing Practice (GMP) which should...
ICH Q2 Guidebook
The ICH Q2 Guideline is a harmonized Guideline in USA, Europe and Japan and was approved in 2005. The guideline covers the validation procedure for an...
IR Explainer
IR Explainer is a user-friendly and versatile App for investigating compound chemical structures using Infrared spectroscopy. It contains database to ...
QSR Booklet
Medical Device Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements an...
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...
GCP Booklet
Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critic...
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...
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...
BLA Booklet
The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate comm...