31 E Kings Highway
2nd Floor
Haddonfield, NJ 08033
Email: info@kenx.org
Phone: 858 649 3251
EDITOR-IN-CHIEF
Kim Huynh-Ba
Managing Director, Pharmalytik LLC
Adjunct Professor, RAQA, Temple University School of Pharmacy
Adjunct Professor, Department of Chemistry, Illinois Institute of Technology
Council of Experts, USP
Fellow, AAPS
This article not only applies to high potent (HP) active pharmaceutical ingredient (API) manufacturing, but it also includes pharmaceutical manufacturing products with HP APIs.
With the rapid rate of digital change nowadays, ensuring data is secure and intact across complicated systems is the biggest challenge for the pharmaceutical industry.
In medical device risk management, the structure of a hazard analysis greatly impacts both product development and post-market surveillance
Combination products are therapeutic and diagnostic products that include two or more of the following: drug, biologic, and device.
This article provides an overview of the receipt, investigation and categorization of product complaints. An example of a product complaint triggered by a serious adverse event is also described.
The Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making...
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