Before any drug intended for human use or chemical and biological products can be distributed and utilized, it must undergo approval by regulatory agencies to ensure its safety and efficacy. This initial step involves the submission of a new drug application to pertinent regulatory bodies, notably the United States Food and Drug Administration (FDA) for…
Post-approval of CMC changes under FDA, EMA and HSA guidance Read More »
The recent pandemic context, as well as unprecedented innovation in advanced therapies, have emphasized the importance, for the pharmaceutical industry, to be able to quickly design and deploy manufacturing processes with high quality and performance levels. The important amount of data, produced and archived along manufacturing activities, constitutes a tremendous source of potential knowledge. The
Improved performance of biomanufacturing processes using data sciences – Part 01 Read More »
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