SCF market access & regulatory affairs
Agata Katia Giuffrida is a Medical Devices Consultant at SCF Studio di Consulenza Farmacologica s.r.l. since January 2017, specializing in regulatory compliance for medical devices in Italy and Europe. Responsibilities include preparing CE marking documentation, ensuring technical documentation conformity, and liaising with notified bodies and qualified laboratories. Prior experience includes a trainee role as a Drug Safety Officer at Sanofi, focusing on pharmacovigilance reporting, and a practical internship at Farmacia Dott.ssa Cuscani, where customer assistance and inventory management were key tasks. Educational qualifications include a Master’s degree in Regulatory Affairs from Università degli Studi di Catania, alongside a Specialist degree in Chemistry and Pharmaceutical Technology and ongoing pharmacist licensure training.
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SCF market access & regulatory affairs
SCF is a consulting agency specialized in market access and regulatory affairs, and a CRO for the conduction of clinical studies about medicinal products and medical devices. SCF supports the pharmaceutical, medical devices and nutraceutical companies from the project phase of new products to the post market phase, with the aim to individuate the regulatory pathways and market access strategies always looking at patients' needs and time to market. our mission is to operate in full compliance with the regulatory field, for the patient's benefits. eCTD, technical dossier for CE marking, notification's documents for dietary supplements and cosmetics, Pricing & Reimbursement dossier and market access strategies for the Italian context: WE KNOW HOW. We also organize training programs in regulatory affairs, pricing & reimbursement, market access, pharmacoeconomic and clinical fields. visit our website! www.studioconsulenzafarmacologica.com