Romanini Advogados was founded in 2010 in response to the needs of companies seeking specialized, high-quality legal advisory services at a cost suited to the reality of small and medium-sized businesses in the healthcare products, pharmaceuticals, and cosmetics sectors.
Since then, more than 300 companies have been served, with over 400 lawsuits aimed at enforcing the law, as well as countless advisory projects that have visibly delivered tangible results to our clients.
Our legal practice is specialized and crafted with care, focused on assisting clients who face challenges in improving health and well-being in Brazil through the introduction of new technologies in medical devices, pharmaceuticals, cosmetics, and all products regulated by ANVISA (the Brazilian Health Regulatory Agency).
About Romanini...
Carla Melo Romanini, registered with the Brazilian Bar Association – São Paulo Section (OAB/SP) under No. 212.497, began her legal career in 1999, working for North American multinational corporations in the telecommunications and healthcare sectors. She has served as a specialist in contract, corporate, and regulatory law at a law firm and worked in the legal department of a Japanese multinational, where she was responsible for contract, corporate (corporate governance), civil, and labor litigation matters.
In 2010, she founded her own law firm — a boutique practice dedicated to providing personalized legal services to clients in sectors regulated by ANVISA and to foreign companies seeking to enter the Brazilian life sciences market.
She holds a Law degree from UniFMU (2001), a Specialization in Contract Law from PUC-SP, and is currently pursuing a degree in Biomedicine at Universidade Estácio. With over 25 years of experience in regulatory, corporate, and contract law, she combines legal expertise with a deep understanding of the life sciences sector.
Some of our services:
HEALTH LAW AND REGULATORY LEGAL ADVICE
Analysis of documents and requirements issued by Health Surveillance Authorities and ANVISA, preparation of responses to ANVISA notifications and official letters, drafting of defenses and administrative appeals against fines or infractions issued by local (City hall) Health Surveillance Authorities or by ANVISA; filing of writs of mandamus aimed at requesting the correct application of the regulations issued by ANVISA.
LEGAL TRAINING, LEGAL PROCEDURES AND POLICIES, AND INTERNAL LEGAL STRUCTURE
Many distributors, importers, and service providers are seeking to adopt structured procedures for their legal matters. In response to this need, Romanini Advogados can also assist your company in the following activities: analysis and drafting of policies and procedures related to the contractual and legal areas; structuring of in-house legal departments; tailored training sessions on the areas of law in which we operate, designed for sales, commercial, or other teams according to the company’s needs; and development, implementation, and training of an Ethical Conduct Code specifically designed for the client’s industry sector.
CORPORATE LAW
The Corporate area specializes in the formation and maintenance of companies, associations, civil society organizations (OSCIPs), NGOs, and foundations, under Brazilian law. Below, we list some services related to Corporate Law: - guidance on the formation of legal entities; - analysis and preparation of documents for companies, associations, and foundations, such as minutes, articles of association, bylaws, and applications; and - procedures before the BOARD OF TRADES, LEGAL ENTITIES REGISTRATION OFFICE, and professional associations for the filing of corporate documents.
ADMINISTRATIVE LAW
In the area of Administrative Law, our advisory services include guidance on national and international bidding processes, as well as support for the analysis of administrative contracts (contracts with public and government entities). Below, we list some services related to Administrative Law: - analysis of bidding notices and documents; - preparation of certificates, appeals, and objections for administrative bidding processes;
- development of controls for managing certificates and documents for bidding processes.
CONTRACTUAL LAW
The Contractual Law advisory services consist of drafting legal instruments and adopting procedures aimed at minimizing risks, uncertainties, disputes, and, consequently, financial losses, by establishing clear rules that govern the relationship between the parties.
Legal guidance in this area is also highly valuable in litigation, as it facilitates — and often ensures — the recovery of rights and credits.
Effective contract management enables the anticipation of potential gains and losses, as well as the maintenance of properly organized files for auditing purposes.
Below are some of the services provided within our Contractual Law practice:
- Analysis, drafting, and negotiation of contracts (both national and international) related to purchase and sale, lease, loan, commodatum, exchange, donation, service provision, pledge, commission, business management, copyright, partnership, insurance, guarantee, transport, supply, real estate development, brokerage, agency, distribution, technology transfer, know-how, licensing, franchising, factoring, engineering, leasing, and other atypical or electronic agreements;
- Analysis and drafting of related documents, such as notices, amendments, dissolution agreements, memoranda of understanding, and letters of intent;
- Preparation of policies, procedures, and standard templates for contractual use and compliance.
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Vanessa Costa – Regulatory Affairs, Unichem Farmacêutica do Brasil
“Carla has always been very competent and dedicated; she has demonstrated not only strong technical skills but also exceptional problem-solving abilities.
More recently, through the consultancy services we hired, I was very pleased with the results, as her team accurately identified our needs and worked with a sense of urgency, proposing practical ideas to overcome regulatory challenges with ANVISA.
I highly recommend the services provided by these excellent professionals.”
Vivian Menocci – Chief Operating Officer (COO), Foccus Medical Equipamentos Médicos Eireli
“Foccus Medical is grateful for the partnership developed with Dr. Carla Melo Romanini’s law firm, which handles our cases with great dedication and care.
Always attentive and involved, she seeks the best solutions and guidance for the success of our business.
A relationship like this would not be possible without the professionalism and competence that she has consistently demonstrated — from simple guidance on new health regulations to more complex legal matters.”
Renata Mendes – Regulatory Affairs, Dako do Brasil
“Dako do Brasil has always relied on your excellent service, the promptness of responses, and the clarity of guidance regarding our regulatory needs.”
Edirlei Novaes – Executive Board, Bone Surgical
“I would like to thank Romanini Advogados, through Dr. Carla, for the excellent work carried out with our company.
Always kind, polite, and competent.
Congratulations once again for your professionalism — my sincere thanks!”
Tatiana Campos – Swiss Business Hub Brazil, Consulate General of Switzerland, São Paulo
“We worked with Romanini Advogados on a delicate project for a Swiss company, and the result was extremely positive.
The client was very satisfied with the quality of the work and the attention provided by Dr. Carla Romanini throughout the entire process.”
Vanessa Costa – Regulatory Affairs, Unichem Farmacêutica do Brasil
“Carla has always been very competent and dedicated; she has demonstrated not only strong technical skills but also exceptional problem-solving abilities.
More recently, through the consultancy services we hired, I was very pleased with the results, as her team accurately identified our needs and worked with a sense of urgency, proposing practical ideas to overcome regulatory challenges with ANVISA.
I highly recommend the services provided by these excellent professionals.”
Vivian Menocci – Chief Operating Officer (COO), Foccus Medical Equipamentos Médicos Eireli
“Foccus Medical is grateful for the partnership developed with Dr. Carla Melo Romanini’s law firm, which handles our cases with great dedication and care.
Always attentive and involved, she seeks the best solutions and guidance for the success of our business.
A relationship like this would not be possible without the professionalism and competence that she has consistently demonstrated — from simple guidance on new health regulations to more complex legal matters.”