High Performance

OUR TEAM

Pedro Cassab
Lawyer

• Graduated in Law at Universidade Paulista, Ribeirão Preto, State of São Paulo – 2001;

• Specialist in Health Law from the Faculty of Medical Sciences, Universidade Estadual de Campinas, in partnership with the Institute of Applied Health Law, with the thesis “The Regulated Power of the National Health Surveillance Agency”– 2010;

• Lead Auditor (GMP) RDC 16 ANVISA, ISO 13485 and 21, CRF 820 FDA/USA GMP, São Paulo–2013;

• Post-graduated in Economic Law from the Faculty of Law of Ribeirão Preto, Universidade de São Paulo (USP) –2016/2017;

• Certified by the Institute of Regulatory Law (IPDR) in Regulatory Pharmaceutical Law, São Paulo – 2018;

• Member of the Health Law Study Group (GEDISA / USP) – 2020.

Practice

Lawyer and Consultant for strategic advisory on matters related to legalization and regularization of companies and products subjected to the Health Surveillance Regime for the safety of operations involving direct participation in structural projects in several segments, such as: food, agrochemicals, cosmetics, Health, medicine and technology. Specialized assistance for the Ministry of Health interpretation of sanitary standards, National Agency of Sanitary Surveillance – Anvisa, Ministry of Agriculture Livestock and Supply (MAPA), Ministry of Industry, Foreign Trade and Services (MDIC), Ministry of Finance, Federal Revenue Secretariat (Customs), Anatel, INMETRO and Environment and Economic Law norms for Defense of Competition of the Secretariat of Economic Law (SDE) and Administrative Council of Economic Defense (CADE), both submitted to the Ministry of Justice. Consultant for new business’ development projects. Specialized advisory for interpretation of sanitary norms and regulatory affairs.

Professional Experience

• Recognized for his strong presence in the regulated health market;

• Columnist in the site Saúde Business with the column “Direito em Pauta” where he addresses issues of greater relevance for the sector;

• Guest speaker at the Training Course for Technical Responsible and Management Representatives RDC 16 / ISO 13458 / ISO 9001 coordinated by the company GMP Consultoria em Gestão Ltda;

• Consultancy and counseling for the structuring of new projects of products and companies submitted to the Health Surveillance Regime with significant optimization of cost and time in the execution of the projects;

• Specialized consultancy support in Regulatory Affairs;

• Consultancy for projects of structuring and restructuring of companies under acts of economic mergers for antitrust defense.

Activities

• Assistance for structuring and restructuring Of companies subject to the Health Surveillance Regime;

• Assistance for business development models for activities subject to the Health Surveillance Regime;

• Consultancy for Product Development with the Regulated Health Sector and Incorporation of New Technologies within the Unified Health System (SUS / ANS);

• Settlement of disputes through administrative procedures;

• Opposition of acts and decisions;

• Elaboration of legal opinions;

• Support in public bidding processes;

• Merger actions inspection;

• Detection support of unfair competition;

• Due Diligencie (M&A).
Successful Cases

• Was a legal advisor in contentious actions of several companies in the medical industry sector, specifically in the execution of projects for product registrations and Good Manufacturing Practices (GMP) certifications of foreign sites with significant reduction of time for product introduction in the national market;

• Acted strongly with foreign companies in the construction of commercial partnerships with local importers creating urgent solutions to start operations;

• Recognized for developing theses through the elaboration of technical opinions and removal of acts creating innovative legal precedents of important relevance for the market;

• Collaborated with mergers’ projects with absolute success to the continuation of the operations.
Class and Order Associations

• Member of the Attorneys’ Association of São Paulo – AASP;

• Member of the Bar Association of Brazil – São Paulo Branch;

• Member of the Bar Association of Brazil – Brasilia Branch.

Languages

• Portuguese
• English

São Paulo

Avenida Dr. Chucri Zaidan . 296

23º andar - Cjto. 231 . Torre Z

Vila Cordeiro - CEP 04583-110

T/Phone + 55 (11) 3376-6343