1. Expert in scientific and regulatory writing with background reflecting experience and knowledge in Pharmaceutical Sciences and various therapeutic areas such as gastroenterology, cardiology, oncology and diabetes.
2. Over eight years of experience in development of novel drug delivery systems for poorly water soluble drugs and protein drugs within academic institutions.
3. Extensive experience in experimental design and data analysis of pharmacokinetics, pharmacodynamics and bioequivalence studies, cell culture studies and histology studies.
4. One year of experience in regulatory submissions of biosimilar and generic products in Latin america and South Africa. Good knowledge of USFDA...
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