Process & Product development

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Medical Devices registration/submission in Israel

2018-12-02T11:43:34+00:00December 2nd, 2018|

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, [...]

OTC Cosmetics Drugs regulation and Good Practices

2020-08-30T09:37:05+00:00February 14th, 2015|

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 [...]

Fermentation in the Bio-Pharmaceutical industry

2014-07-30T07:20:07+00:00July 30th, 2014|

[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. [...]

Good Weighing Practice for lab and production balance

2013-06-18T07:20:33+00:00June 18th, 2013|

[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 [...]

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