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BIOBETTERS: THE BETTER BIOLOGICS AND THEIR REGULATORY OVERVIEW
This review will focus on technical and regulatory prospects of biobetters. ... Sandeep et al. International Journal of Drug Reg ulatory Affairs; 2016, 4(1), 13 ... International Journal of Drug ...
Regulatory Affairs: an Overview | PharmaTutor
Regulatory Affairs is a unique mixture of science and management to achieve a commercially important goal within a drug-development organization. Regulatory Affairs takes care of Development plan, supervising-writing / reviewing and assembling and submission management.
Regulatory Affairs - an overview | ScienceDirect Topics
Toby Freedman PhD, in Biotechnology Entrepreneurship, 2014. 8 Regulatory Affairs. Regulatory affairs liaisons manage the process of working with project teams and interacting with the regulatory health agencies, such as the Food and Drug Administration (FDA) or the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)....
(PDF) INTERNATIONAL CONFERENCE ON HARMONISATION: AN OVERVIEW
The International Conference on Harmonisation (ICH) is a project that makes together the regulatory bodies of Europe, Japan and the United States and professionals from the pharmaceutical domain ...
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