Dara Offrede

Attorney

Bio

Dara's practice concentrates on high-complexity transactional, regulatory and intellectual property matters, with a focus on the pharmaceutical, MedTech and agribusiness industries. With deep understanding of the regulatory and market practices in Brazil, Dara has a proven track record of providing vital guidance to clients, ensuring strategic protection of their business interests. This includes strategic advice and support on all stages of a product's lifecycle, from clinical trials to commercialization, and the enforcement of IP rights for medicines, biological products, medical devices e agriculture products. 

 

As a skilled litigation attorney, Dara experience also includes handling complex litigation against regulatory and government agencies such as the Brazilian Health Regulatory Agency (Anvisa), the Brazilian Drug Market Regulation Chamber (CMED) and the Ministry of Agriculture, Livestock, and Food Supply (Mapa).

Education

- J.D. from Universidade do Estado do Rio de Janeiro (UERJ).

- Specialization candidate in Regulatory Law at Universidade do Estado do Rio de Janeiro (UERJ) - expected graduation: 2026.2.

Languages

Portuguese, English, French

Publications

Life Sciences & Health
Life Sciences & Health

Brazil Tightens the Screws on Technology Transfer Pricing in Productive Development Partnerships: What the Ministry of Health's New Methodology Means for IP Holders

Brazil's Ministry of Health issued a new methodology for valuing technology transfer in PDPs, establishing pricing benchmarks and reimbursement rules for IP.
2026
8
min read
Life Sciences & Health
Life Sciences & Health

Hot Topics: A Complete Guide on What to Expect in Life Sciences Regulated Sector in 2026

A comprehensive outlook on the 2026 regulatory landscape for Brazil's Life Sciences sector, covering CMED pricing, Anvisa's sandbox, and clinical trials.
2026
5
min read
Life Sciences & Health
Life Sciences & Health

Brazil and the Productive Development Partnerships (PDPs): Setting Up Pricing for Tech Transfer and IP Protection

Brazil implements new pricing criteria for technology transfer in Productive Development Partnerships (PDPs) to ensure transparency and SUS fiscal responsibility.
2026
6
min read
Life Sciences & Health
Life Sciences & Health

New Drug Pricing Regulation: An Overview of CMED Updated Framework for Pricing Approval

Brazil's CMED introduces Rule No. 3/2025, modernizing drug pricing regulation by expanding categories, redefining therapeutic gain, and updating country references.
2026
5
min read
Life Sciences & Health
Life Sciences & Health

Brazil Regulates Clinical Research: A Complete Review of Decree #12,651/2025 - Part 2

Brazil's Decree #12,651/2025 regulates the Clinical Research Act, establishing SINEP and balancing ethics with efficiency, analyzed here in Part 2.
2025
9
min read