RABELO LAW

Firm Overview:

Rabelo Law is a boutique law firm focused on Life Sciences & Healthcare, that provides its clients with an unique combination of solid transactional, M&A, Corporate, contract, health data privacy and compliance experience, with a vast regulatory knowledge.

We are a specialized law practice, with a pioneering position and professionals who understand the nuances of our clients’ businesses. Above all, we believe in a simple and efficient law practice, for the benefit of our clients, business partners and people.

The Firm’s founding partner, Elysangela Rabelo, has more than 20 years of experience with a wide range of clients in the pharmaceutical, medical devices, health products, cosmetics, and food industries, and with hospitals, retail clinics, lab analysis, healthtechs, and health insurance companies.

Simone Lima Dainezi Rabelo is a lawyer with broad expertise in health law and in the supplementary health sector. She has been practicing for several years in civil litigation involving health related matters. Simone provides legal advice in civil law, consumer law, and health regulatory.

We are a specialized law practice, with a pioneering position and professionals who understand the nuances of their clients’ businesses. Above all, the firm believes in a simple and efficient law practice, for the benefit of their clients, business partners and people.

Whether you are a domestic or global pharma or medical device company, a clinical research organization, or a digital health innovator, our expertise will help you accomplish your goal by guiding you through the complex Brazilian regulatory, and compliance environment.

Practice Areas:

The areas of practice include the assistance in corporate, contract, foreign investments, incorporations, structuring of joint ventures, corporate reorganizations, and mergers, spin-offs, and acquisitions of companies, and regulated assets.

In the corporate area, the Firm is ready to advice on regulations issued by the Brazilian Ministry of Health (MS), the National Agency for Health Plans (ANS), the National Health Surveillance Agency (ANVISA), and other regulatory authorities and health professional councils; advice on clinical research matters, Digital Health initiatives, including in health data privacy matters; legal advice on the obtaining of licenses and marketing authorizations, as well as on administrative proceedings before health authorities.

The Firm also assists clients in avoiding, and resolving legal disputes, related to health and life sciences regulations.

Regulatory:

• Advising on matters related to regulations issued by the Brazilian Ministry of Health (MS), the National Agency for Health Plans (ANS), the Supplementary Health Counsel (CONSU), the National Health Surveillance Agency (ANVISA), the National Counsel of Health (CNS), the Drug Market Regulatory Board (CMED), health professional councils, such as medicine, pharmacy, nursing, nutrition, among others;
• Advising on clinical research matters, including drafting or reviewing investigational agreements and protocols, as well as informed consent forms;
• Assistance on Digital Health initiatives like telemedicine and telehealth, including on health data privacy matters;
• Legal Assistance with proceedings for obtaining licenses and marketing authorizations before the relevant governmental and regulatory authorities;
• Assistance in administrative proceedings with health authorities in the federal, state, and local levels;
• Assistance in corporate, contract, and regulatory matters related to public-private partnerships (PPPs) in the health sector, and productive development partnerships (PDPs) in the pharma sector;
• Assistance with industry-specific compliance matters.

Contracts:

• Drafting, and negotiating of supply, distribution, services, licensing, technology transfer, manufacturing, and supply agreements (MSA), full manufacturing agreements, toll manufacturing agreements, quality assurance agreements, among others.

Corporate, Mergers and Acquisitions:

• Assisting in foreign, and domestic investments, incorporations, mergers, spin-offs, and acquisitions of companies, and regulated assets;
• Structuring of joint ventures and Corporate reorganizations;
• Private equity transactions, including investments, divestitures and legal assistance to portfolio companies;
• Assistance in corporate, contract, and regulatory matters related to public-private partnerships (PPPs) in the health sector, and productive development partnerships (PDPs) in the pharma sector.

Dispute Resolution:

• Assisting clients in avoiding, and resolving legal disputes, involving health and life sciences regulations;
• Assisting in administrative, and judicial proceedings, involving health related matters.

Rabelo Law works in cooperation with other professionals specialized in antitrust, tax, environmental, labor and other areas, to provide our clients with complete solutions in projects requiring other expertise than the ones we can provide as a boutique law firm.

Besides, for the broad international experience of its Founding Partner, Rabelo Law is part of vast network of international law firms , which enables us to exchange legal developments in different jurisdictions, have access to specialized professionals working in our field of law and, most importantly, provide our clients with reliable referrals for international legal matters.

Firm Overview:

Rabelo Law is a brazilian law firm that provides legal solutions for the Life Sciences and Healthcare sectors, in transactional, M&A, contract, corporate, regulatory, and dispute resolution matters.

The Firm’s founding partner, Elysangela Rabelo, has more than 20 years of experience with a wide range of clients in the pharmaceutical, medical devices, health products, cosmetics, and food industries, and with hospitals, retail clinics, lab analysis, healthtechs, and health insurance companies.

Simone Lima Dainezi Rabelo is a lawyer with broad expertise in the supplementary health sector. She has been practicing for several years in civil litigation involving health related matters. Simone provides legal advice in civil law, consumer law, and health regulatory.

We are a specialized law practice, with a pioneering position and professionals who understand the nuances of their clients’ businesses. Above all, the firm believes in a simple and efficient law practice, for the benefit of their clients, business partners and people.

Whether you are a domestic or global pharma or medical device company, a clinical research organization, or a digital health innovator, our expertise will help you accomplish your goal by guiding you through the complex Brazilian regulatory, and compliance environment.

Practice Areas

The areas of practice include the assistance in corporate, contract, foreign investments, incorporations, structuring of joint ventures, corporate reorganizations, and mergers, spin-offs, and acquisitions of companies, and regulated assets.

In the corporate area, the Firm is ready to advice on regulations issued by the Brazilian Ministry of Health (MS), the National Agency for Health Plans (ANS), the National Health Surveillance Agency (ANVISA), and other regulatory authorities and health professional councils; advice on clinical research matters, digital Health initiatives, including in health data privacy matters; legal advice on the obtaining of licenses and marketing authorizations, as well as on administrative proceedings before health authorities.

The Firm also assists clients in avoiding, and resolving legal disputes, related to health and life sciences regulations.

Regulatory

• Advising on regulations issued by the Brazilian Ministry of Health (MS), the National Agency for Health Plans (ANS), the Supplementary Health Counsel (CONSU), the National Health Surveillance Agency (ANVISA), the National Counsel of Health (CNS), the Drug Market Regulatory Board (CMED), health professional councils, such as medicine, pharmacy, nursing, nutrition, among others;
• Advising on clinical research matters, including drafting or reviewing investigational agreements and protocols, as well as informed consent forms;
• Advising on digital Health initiatives like telemedicine and telehealth, including on health data privacy matters;
• Legal Assistance with proceedings for obtaining licenses and marketing authorizations before the relevant governmental and regulatory authorities;
• Assistance in administrative proceedings with health authorities in the federal, state, and local levels; Assistance in corporate, contract, and regulatory matters related to public-private partnerships (PPPs) in the health sector, and productive development partnerships (PDPs) in the pharma sector;
• Assistance with industry-specific compliance matters.]

Contracts

• Drafting, and negotiating of supply, distribution, services, licensing, technology transfer, manufacturing, and supply agreements (MSA), full manufacturing agreements, toll manufacturing agreements, quality assurance agreements, among others.

Corporate, Mergers and Acquisitions

• Assisting in foreign, and domestic investments, incorporations, mergers, spin-offs, and acquisitions of companies, and regulated assets;
• Structuring of joint ventures and Corporate reorganizations;
• Private equity transactions, including investments, divestitures and legal assistance to portfolio companies;
• Assistance in corporate, contract, and regulatory matters related to public-private partnerships (PPPs) in the health sector, and productive development partnerships (PDPs) in the pharma sector.

Dispute Resolution

• Assisting clients in avoiding, and resolving legal disputes, involving health and life sciences regulations;
• Assisting in administrative, and judicial proceedings, involving health related matters.