Team Expertise

The highly qualified RPN team includes internal and external regulatory affairs specialists with competences and expertise in different fields: medicinal products including advanced therapies and orphan drugs, medical devices, cosmetics, biocides, food supplements.

Anita Falezza founded Regulatory Pharma Net s.r.l. in 1999, after having held various positions in the pharmaceutical industry since 1989, such as Regulatory Affairs Director, International Regulatory Affairs Manager, Study Director.

Her activities are focused in consulting and strategic coordination of Drug Development and Regulatory Affairs projects in Europe.

She has directly participated in Price and reimbursement procedures, Scientific Advice, Paediatric Investigation Plans, Orphan Drug Designations, Drug Development Plans, Centralised, Decentralised, and Mutual Recognition Procedures, Due Diligences being in continuous contact with the evaluating authorities. She has remarkable experience in Innovative Products, Anticancer products, Biological and Biotechnological Products, and Advanced Therapies.