BPx Consulting was founded to help life science companies, professionals and suppliers work in accordance with the good practices established by regulatory agencies such as ANVISA, FDA, WHO, EMA, INVIMA, INMETRO, MHRA with the aim of ensuring processes compliance and their continuous improvement. We offer solutions for quality, regulatory affairs, validation and engineering field so that your company can focus on strategy.
This article is complemented by: Validação de Sistemas Computadorizados Validação de Sistemas Computadorizados Agile e CSA By Gustavo Soares and Thiago Borin Evaluation based on GAMP 5, 21 CFR Part 11, and the […]
Read MoreImplementation of AI and ML in the Pharmaceutical Industry: Impact, Standards, and Guidelines By Gustavo Soares Abstract With the advancement of Artificial Intelligence (AI) and Machine Learning (ML) in the pharmaceutical industry, new […]
Read MoreThe FDA Form 483, issued by the Food and Drug Administration (FDA), is an official document used by the agency to communicate to a company the conditions or practices observed that may violate […]
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