Aline Coelho is a lawyer of the Life Sciences and Health department in Rio de Janeiro.
Aline’s pratice focuses on Life Sciences and Health, including regulatory, administrative and judicial litigation.
Brazilian Bar Association (OAB).
Member of Sanitary and Health Law Commission of the Brazilian Bar Association, Rio de Janeiro (OAB/RJ).
Ranked among the top Brazilian lawyers in 2020 and 2021, in the Regulatory area, by the Analysis Advocacia 500, and in the Regulatory and Health areas in 2021 and 2022, in the Analysis Advocacia Woman Ranking.
Bachelor of Laws at Universidade Estácio de Sá, 2003.
Post Graduation course in Constitutional, Administrative and tax Law at Universidade Estácio de Sá, 2008.
Portuguese and English
LIFE SCIENCES AND HEALTH
• Organization and Regularization of companies to start operating in Life Sciences area and Health.
• Regulatory Strategy for the development, concession and/or renewal of products submitted to the Brazilian National Health Surveillance System.
• Regularization of product prices before the Brazilian Regulatory Chamber of the Medicines Market (CMED).
• Evaluation of marketing measures from legal standpoint in face of the health legislation.
• Government Relations in strategic cases involving the Brazilian Health Regulatory Agency (Anvisa), Ministry of Health and CMED.
• Monitoring of issues of interest being reviewed by the National Congress or discussed by the Federal Government and the Regulatory Agencies.
• Risk analysis and advice on strategic actions.
• Administrative and judicial litigation in all matters in connection with health issues.
LITIGATION AND ARBITRATION
• The litigation team strategically takes part, and may even leads it according to the case, into negotiations, business transactions, contractual discussions and others, adding a different perception to the matter. • Litigation involving matters of several natures, such as civil, business, consumer, sports law, infrastructure, bankruptcy and reorganization (receivership), real estate and intellectual and industrial property law. • Solid experience in national and international arbitrations before the most renowned domestic and foreign institutions. • Legal advice to prevent disputes in general and to mitigate risks and possible damages as well, either by providing legal opinions or legal counseling in a more dynamic and informal manner. • Legal assistance on pre-litigation scenarios. Along and in partnership with our clients, our litigation team will define the best strategy to build a strong and reliable case to be presented in Court. • Economic analysis of judicial claims of the companies, providing a trustable profile of the chosen company in regards of the lawsuits in which it’s involved and the economics risks associated with. • Legal opinions in civil matters.
• Drafting of legal opinions, due diligence reports and regulatory assessments, as well as preparing draft bills of law, decrees, resolutions and other enactments; monitoring and participation in public consultations and hearings from the National Congress and Regulatory Agencies, workshops and discussion forums in technical committees and industry events.
• Legal advice throughout the development from planning to implementation of major projects of energy, oil and gas, mining, transportation, logistics, sanitation, life sciences, telecom, ports, airports, among others.
• Drafting, negotiating, reviewing and risk assessment of various industry specific agreements.
• Legal assistance in public bidding procedures promoted by Regulatory Agencies such as ANP, Anatel and Aneel (follow-up and review of tender protocols, preparation of requests for clarification, challenges and appeals, risk matrix of administrative contracts, assistance for participation and qualification to bid).
• Prevention and representation in strategic conflicts involving regulatory matters, in administrative and judicial litigation and mediations, domestic and international arbitration.
• Advice related to the obtainment of granting instruments, licenses, concessions, authorizations, registrations, homologations and certifications, as well as approvals and notices.