Saeed A. Qureshi, Ph.D.
Principal
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Extensive (30+ years) working experience in a regulatory agency (Health Canada), has provided Dr. Qureshi with a deep understanding of the underlying issues facing both regulatory authorities and pharmaceutical industry related to quality assessment of products. He was involved in reviewing Drug Applications, as well as providing advice as an expert on the subject. As a senior research scientist, Dr. Qureshi has conducted experimental studies relevant to the assessment of Drug Applications. He has conducted hands-on experimental studies, both in vitro (dissolution/release) and in vivo (bioavailability/bioequivalence), as relevant to the review of Drug Applications. He has developed both instrumental and mathematical methods to provide simpler and efficient analytical approaches applicable to the manufacturing of quality products. Such multifaceted knowledge and experience makes him an un-matched authority on the subject from both perspectives; manufacturing and regulatory.
In this regard, Dr. Qureshi maintains a full command in the areas of pharmacokinetics, biopharmaceutics, analytical chemistry as related to animal and human studies for developing and evaluating products. He has extensively published in peer-reviewed journals, as well as made numerous invited international presentations on the subjects. He is an accomplished scientist from a regulatory organization as reflected by a number of high profile awards he has received such as: (1) Life-time Achievement Award (2015, Indus Foundation, India); (2) 2007 Deputy Minister’s (Health Canada) Award of Excellence in Science; (3) Excellence in Science Award (2007, Health Canada).
His expertise and experiences would be of great help to any organization seeking advice/consultation in designing study protocols, monitoring/observing studies, interpretation and write-up of studies, in particular, for senior managers and decision makers. Dr. Qureshi’s abilities would shine in situations where there are difficult issues of unexplained behaviours of products both in vitro and in vivo.