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QSR Booklet
Medical Device Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements an...
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...
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...
IND NDA Booklet
In US, current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across sta...
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...
Recalled
Recalled! retrieves all Recalls, Recall Alerts and Press Releases from the US Consumer Product Safety Commission (CPSC) and Recalls and Safety Alerts ...
EU-GMP Annex1
Good manufacturing practice (GMP) is the key part of the quality assurance for medicines in the European Economic Area (EEA). The manufacture of steri...
GMP Cast 굿모닝팝스 플레이어 광고제거
' 굿모닝팝스 ' 방송듣기를 가장 편하게 들을 수 있도록 만들었습니다.사용해보시고문제있거나 원하는 기능있으면 언제든지 의견 주세요.빠른 시일내에 더 좋은 굿모닝팝스 플레이어로 만들겠습니다.모두가 굿모닝팝스를 가장 편하게 들을 때까지...Best Good ...