Brazilian Market Access expert
Sheila is a graduate in pharmacy and biochemistry and has a specialization course in Pharmaceutical Industry, Quality and Productivity. Sheila is Brazilian and is an expert on the interpretation of the Brazilian regulations (ANVISA/INMETRO). She supports companies for Brazilian market access, from regulatory pathways, classification, and complete registrations to support in auditing for Brazilian GMP.
Sheila’s expertises are in process validations, preparation of rationales for completely novel devices, devices incorporating medicinal substances or animal tissues, and borderline products. Sheila is working on customer projects as a consultant to support medical device manufacturers with the preparation of technical files, process validations, CAPA, and of course the Brazilian registration. Prior to Qserve Sheila worked (10 years) in a female health company as QP person and as technical responsible, quality system and regulatory affairs manager.