The rapid advancement of technology in the medical device industry has dramatically transformed healthcare delivery, while also presenting new challenges…
Registered the first retractable syringe with ANVISA
Registered the first laryngeal mask at ANVISA
Authorized the first insecticidal paint at ANVISA
Reversed the cancellation of the largest Cannabidiol Oil tender in Brazil
Founding partner of Emergo Group in Brazil
Lawyer specializing in Health Law, Executive MBA in Marketing with solid experience in the Health Products industry acting as Director of Regulatory Affairs since 1995. Professional experience: Senior Director of Health Regulatory Affairs in the Latin American market. Deep experience in due diligence and M&A activities associated with product licensing and product/company integrations and transfer of ownership of records between companies. Multidisciplinary vision with an approach from the legal, regulatory, commercial and public bidding aspects for the Brazilian market. International speaker on the regulatory environment and the Brazilian market. Serial entrepreneur. He is currently the CEO of the consulting company Brisa Advisors and the Records Hosting company BIHS.
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Lawyer specializing in public tenders, national and international contracting and regulatory law. He has worked for more than 80 foreign companies from 15 countries. He has a postgraduate degree in Public Law from IDP-Brasília, and is a former advisor to the Presidency of the Republic. Author of five books, including “International Public Tendering in Brazil”, in addition to the AMCHAM legal guide “Howto do GovernmentContracts in Brazil”. Speaker at more than 140 events in 18 states and internationally in Washington, New York, Houston, Miami, Boston, Buenos Aires and Hong Kong. He taught courses for entities such as the Presidency of the Republic, Ministry of Foreign Affairs, Ministry of Health, Army, Navy, Air Force, Federal Revenue and others. Experienced in regulation, including in the areas of medical devices, products for hospitals, airports, defense and security, technology and other areas.
PhD in materials engineering, specialist in product development and validation of materials and processes for the healthcare sector. He has more than 25 years of experience as a development manager, regulatory affairs and as a consultant for national and multinational companies in the areas of orthopedic implants, dental implants and surgical instruments. Part of its activities is the evaluation of product design information to produce evidence of regulatory compliance, clinical and engineering analyses, as well as the construction of the technical dossier for product registration.
Bachelor of Law, with more than 10 years of experience in providing administrative support to public and private companies. Extensive experience in preparing official and internal documents, implementing procedures, managing teams, complying with labor legislation in Brazil and office administration. He worked for more than 5 years as Operational Manager of EmergoGroup branches in Brazil, being responsible for the financial and administrative management of the Brasília and São Paulo offices. In 2021 he founded the company Zermatt Consulting, which provides administrative services on an outsourced basis, with the Brisa Advisors group as a business partner.
Biologist and Pharmacist with 16 years of experience in the areas of Regulatory Affairs, Quality Management and Research and Development of Medical Devices. Experiences in industries and distributors of medical devices, including devices for in vitro diagnostic use. Internal auditor ISO 9001:2015. Specialist in Health Surveillance and Strategic and Quality Management. Experience in working with multidisciplinary teams, especially the Regulatory x Marketing interaction.
It joined the Brisolla Advogados Associados Law Firm based in the Federal Capital since the installation of the Superior Court of Justice and Federal Supreme Court in 1960. The office represented ABIFARMA (Brazilian Association of the Pharmaceutical Industry), among other unions in this segment, during the implementation of the Generic Medicines Law in the country.
“Our company has a big challenge in Brazil, we started from scratch all the regulatory processes in the country: INMETRO and ANATEL certifications, Brazilian Good Manufacturing Practices, and ANVISA registrations.
We are under the BPO in RA with Brisa, it was an excellent choice for Lumenis Be since Brisa guides us professionally in these regulatory steps. The Brisa team answers our questions and doubts daily, they give us enormous support to make decisions and plan our regulatory strategy in this country; we trust their suggestions and experience.”.
Silene Bertelli – Regulatory Coordinator Lumenis,
https://lumenis.com/
“Comprehensive experience and understanding of Brazilian regulatory and reimbursement laws and practices. Experience helping companies with strategy, planning and navigating the complex process of obtaining new regulatory product registrations and product renewals. Has long-standing professional relationships with Brazil's regulatory and reimbursement administrations and community of regulatory lawyers and technical consultants Accessible, responsive, ethical, practical, innovative, hardworking, Trustworthy advice; without sugarcoating or telling customers what they want to hear. Ability to provide realistic assessments of the technical process requirements and timeline for development and processing of regulatory filings.”.
David Kravitz – CEO Organ Recovery,
https://organ-recovery.com
“I recognize your excellent professional competence in the national and international regulatory area based on your personal skills and long experience. A competent and professional service, not only corporate and/or commercial, that can support the company as part of its internal team in the business strategy of penetrating international markets as much as possible, obtaining the necessary authorizations in compliance with legislation and Objectives and timing of the company. Expert, Results-oriented, Professional.”
Elvira Taccarelli - Regulatory Affairs Manager - Orthofix Srl
https://www.orthofix.com/
“Reliability, knowledge and quick response. Solving regulatory issues problems in a simple and objective way. Technical capacity to work in the legal sphere. Knowledge of the pharmaceutical and medical device markets".
Carlos A. F. de Loureiro – General Manager
www.organ-recovery.com
The rapid advancement of technology in the medical device industry has dramatically transformed healthcare delivery, while also presenting new challenges…
In recent years, the medical device industry has undergone a profound transformation driven by technological innovations. Technologies such as artificial…
