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Pharmaceutical and regulatory law
Legal counsel for pharmaceutical operations in Brazil
Administrative proceedings before ANVISA, import and export, international contracts and customs matters. International enquiries are welcome, preferably in English.
Rafael Leite Mastronardi · OAB/PR 79.209 · Curitiba, Paraná, Brazil
Context
Brazilian pharmaceutical regulation, from a legal perspective
Pharmaceutical operations in Brazil involve the regulatory system built around ANVISA, corporate requirements and controls on the import and export of medicines.
The requirements that apply depend on the product and on the operation. This page presents the areas in which the firm provides legal counsel.
Practice
Areas of legal counsel
Each matter is assessed according to the product, the parties involved and the intended operation.
01
ANVISA proceedings
Legal counsel in administrative proceedings before ANVISA, including responses to technical requirements and defense against administrative penalties.
02
Company and product regularization
Legal counsel on the regularization of companies and products in the pharmaceutical sector, including operating authorizations (AFE and AE, where applicable) and matters arising from sanitary inspections.
03
Import and export
Legal counsel on the regulatory aspects of importing and exporting medicines, according to the product and the operation.
04
International contracts
Legal counsel on international contracts related to pharmaceutical operations in Brazil.
05
Customs matters
Legal counsel on customs matters related to medicines, including shipments held at customs and disputes over documentation.
Who we advise
The pharmaceutical sector, in Brazil and abroad
Our legal work in the medicines sector takes into account the regulatory particularities of each product and operation.
- Manufacturers
- Distributors
- Importers and exporters
Individuals may also consult the firm, subject to case assessment.
International service, preferably in English.
The firm
Mastronardi Advocacia
Brazilian law firm based in Curitiba, Paraná, with a full-service practice for companies and individuals. Rafael Leite Mastronardi is registered with the Bar of the State of Paraná (OAB/PR 79.209).
See also: Pharmaceutical and Health Regulatory Law and all practice areas.
Contact
Contact the firm
Tell us about your company, the product and the legal matter.
Informational content. It does not constitute legal advice and does not imply any outcome. Each case depends on the facts and the documents.