Natalia Bellan

Dr. Natália Bellan is Bachelor of Pharmacy and Biochemistry (PharmD) at Universidade Estadual Paulista (UNESP), Master of Research and PhD in Pharmaceutical Sciences with research line in Regulatory Science (Regulatory Affairs) at the University of São Paulo (USP) and a member of the Regulatory Affairs Professionals in Europe (Topra) and Registered in the Class Pharmaceutical Council in Brazil. Technique in buildings with expertise in planning and projects at the Federal Technical School of São Paulo (CEFET-SP).

Has more than 12 years of experience in Global Regulatory Affairs & Compliance: technical, regulatory and governmental / political area of medicines, medical devices, cosmetics, foods and technological innovations working mainly in quality assurance, quality control, stability of drugs, critical design and GAP analysis of technical documentation for registration (CTD / dossier), preparation technical and regulatory advice to legal proceedings of patents and trademarks, evaluation of innovative projects for investors, administrative resources of regulatory agencies, consumer protection, due diligence, etc.

Experience in audits mainly covering: ISO 13485:2016, ISO 14971:2009, Directive 2017/745/EC (93/42/EC), FDA CFR 21, RDC 16/2013, RDC 185/2001, RDC 301/2019, etc. And experience in different regulatory agencies and government institutions such as: ANVISA, MAPA, COVISA, INMETRO, EMA, ISO, AIFA, AEMPS, COFEPRIS, INVIMA, ANMAT, USP, etc.

Develops educational and research projects in Regulatory Affairs since 2006. Author of books and technical articles in Regulatory Sciences.

Has experience managing different projects in the pharmaceutical industry as: United States Pharmacopeia (USP), Biotest, Vosing Consulting EU, DextReg EU, Glenmark Latam, Bausch-Lomb – Valeant, Silimed, Novartis-Alcon, IGL-Sanofi, Merck-Cubist, Baldacci, Becton Dickinson (BD), ABIQUFI, ABRAIDI and Fipfarma-FURP.  

Main countries: BRICS (Brazil, India, China), LATAM (Argentina, Costa Rica, Peru, Mexico, Chile, Colombia, Paraguay, El Salvador, Guatemala, Dominican Republic, Nicaragua, Uruguay, Venezuela, etc), EU (France, Italy, Germany, England, Spain, Portugal, Luxemburg, etc) and USA.

Main products - medical devices: dental implants, dental line, breast implants, intraocular lenses, the entire line of ophthalmology, instrumentation for surgery, equipment with coupled software, organ transplantation solutions, cardiac surgery equipment, in vitro diagnostics, laboratory equipment and instruments, etc.

Main products - medicines: oncological line, ophthalmology, orphan drugs, cardiovascular, herbal medicines, biological medicines, OTC, generics, vitamins, etc. 

Multicultural experience, having worked and resided in different countries such as Brazil, Spain, Italy, Malta and England. Nacionality: Italian.

Main line of research: International Sanitary Regulations

Specific lines of research:

• Regulatory Affairs of  human and veterinary pharmaceutical products (medical devices, medicines, combined products, foods, cosmetics).
• Research in Regulatory Science applied to the development of new global strategies for innovative product launches in the pharmaceutical industry.
• Research in Regulatory Science applied to the Pharmaceutical Industry.
• Regulatory Science Research Applied to Government Agencies (Regulatory Agencies, Ministry of Health, Third Party Institutions).
• Research projects in regulatory affairs with the certification goal of manufacturers, importers, distributors and quality control laboratories in the global scope and for the different types of products.

• Regulatory Affairs of human and veterinary pharmaceuticals products (medical devices, medicines, combined products, foods, cosmetics).
• Regulatory Intelligence.
• Sanitary Law.
• Pharmaceutical Law.
• Sanitary legalization of the pharmaceutical industries.
• Pharmacoeconomics.
• Compliance in the pharmaceutical sector.
• Regulatory science.
• Deontology and code of ethics for pharmacists.