Felipe Gilio

Background

About Felipe Gilio

I am a professional pharmacist with 12 years of experience in medium-sized Pharmaceutical Industry. I´ve worked with Regulatory Affairs, Method Validation and Quality Control.Solid knowledge in: • Process validation (forms solid pharmaceutical orals and injectable), analytical methods and cleaning validation;• Organic synthesis;• Product development processes in pharmaceutical industry;• Technologies involved in quantification of analytes;• Statistical assessments and understanding of statistical methodology in clinical sciences;• Project management;• Design and planning of bioequivalence and relative bioavailability studies of innovative, generic, similar and post-registration drugs;• Clinical, analytical and statistical stages of bioequivalence / bioavailability studies and national and international standards;• Elaboration of technical-scientific rationales for presentation/discussion with ANVISA (National Health Surveillance Agency of Brazil);• Elaboration of technical rationales for bio wavers purposes;• Evaluation of physiological and bio relevant medium that complement the in vitro assays previously performed to the in vivo test;• Evaluation of formulations in order to correlate their performance with the expected behavior of the present drug in relation to its class in the Biopharmaceutical Classification System;• Validation of strategies with National Health Surveillance Agency of Brazil;• HPLC, GC, LC-MS, UV Spectrometry, IR, Dissolution Profile.Professional with strong relationship and cooperation with analytical, Galenic formulation, regulatory and new business teams for schedule alignment and project execution.