Greetings Folks,

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I am extremely pleased to introduce you the highly dynamic and exciting world of Bioanalytical Science – The “Regulated Bioanalysis”

“As decay in quality standards is quite inevitable due to human interventions, the avoidance strategy necessitates well directed efforts, active participation and continual contribution from key stakeholders like doers (laboratory professionals), quality professionals (QC/QM/QA) and management (leadership) as well”

Basic Science and Regulatory considerations, with ‘quality’ as the focal point are two vital components of Regulated bioanalysis (RegBio). With the advancement in scientific practices through continuous learning, RegBio has progressed significantly in the past two decades. At the same time, technological advancements and new regulatory requirements have propelled local and international regulatory agencies to bring about constructive improvements to their regulatory guidance and other relevant documents (EMA, USFDA, ICH M10 – BMV guidelines and OECD, MHRA, WHO – Data integrity guidelines). Thus, the dynamism of RegBio demands not only sound scientific knowledge but also correct understanding of quality standards and regulatory aspects. The conceptualization, creation and implementation of an appropriate ‘Quality Management System (QMS)’ for a bioanalytical lab and CRO necessitate focussed and sustained efforts from the doers (analysts, laboratory professionals), quality professionals (QC/QM/QA) as well as the management (leadership). With inference to decades of globalized practices and hands on experience, it is clearly understood that ‘Quality’ is a culture-driven phenomena, and needs to be inculcated in professionals and incorporated in the working culture of an organization at the very onset.

Once again;

WELCOME  to the passionate world of Bioanalytical Science !

Keep Moving ! Keep Working ! See at Work !