The process of pharmaceutical drug products registration in Israel The main regulatory body in the pharmaceutical administration in Israel is the Registration Department of the Israeli Ministry of Health [...]
The process of pharmaceutical drug products registration in Israel The main regulatory body in the pharmaceutical administration in Israel is the Registration Department of the Israeli Ministry of Health [...]
The process of Medical Device registration and submission in Israel In Israel, the regulatory body that is responsible for Medical Device submission, registration, supervision and control over the manufacture, assembly, [...]
Medical device surface treatment Surface roughness level is a parameter of the surface quality commonly measured as the average deviation of the surface profile from the mean line (Ra). [...]
[vc_row][vc_column][vc_column_text] 1. Background After new investigational drug pre-clinical stage 1 was completed, and IND (Investigational New Drug application) or CAT (Clinical Trial Application) submission to the FDA or CE [...]
Background and history In 1938, the FFDCA (Federal Food, Drug and Cosmetic Act) granted FDA cosmetic products and ingredients regulation authorization. The statutory provisions of the FFDCA addressing cosmetics [...]
[vc_row][vc_column][vc_column_text] 1. Background Many Bio-Pharmaceutical and biological products are based on (different) cell-type fermentation. Bio-Pharmaceutical products can be either intra or extra cellular metabolites that have a pharmacological effect. [...]
[vc_row][vc_column][vc_column_text] 1. Background and history The FDA (U.S Food & Drug Administration) was established in 1901 as a bureau of the Chemistry Department of Agriculture. Five years later, a [...]
Background Good Storage and Distribution Practice (GSP/GDP) describes human, veterinary and investigational drug substance and drug products supply chain procedures and standards in order to assure the biological/pharmaceutical product [...]
[vc_row][vc_column][vc_column_text] 1. Introduction Weighing raw materials, product, reagents, excipients and other product related materials is a risk procedure in the Biotechnology and Pharmaceutical areas. Any weighing mistake in case [...]