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

Legal & Regulatory Updates
Legal & Regulatory Updates

Brazil Regulates Clinical Research Act: A Complete Review of Decree #12,651/2025 - Part. 1

Decree 12,651/2025 operationalizes Brazil’s Clinical Research Act by establishing SINEP/INAEP, enforcing binding ethics and regulatory timelines, enabling single-CEP opinions for multicenter trials, and opening integrated INAEP–Anvisa procedures—setting the stage for faster, more predictable studies.
2025
7
min read
Legal & Regulatory Updates
Legal & Regulatory Updates

Updates on the Brazilian Clinical Research Landscape: What’s at Stake in ADI 7875

ADI 7875 challenges key provisions of Brazil’s Clinical Research Act on constitutional grounds—post-trial access, consent in emergencies, institutional liability—putting legal certainty at risk even as long-awaited regulations near publication.
2025
8
min read
Life Sciences & Health
Life Sciences & Health

Brazilian Clinics and the False Equivalence of Compounded GLP-1 Drugs: ANVISA should follow FDA

U.S. FDA enforcement against compounded GLP-1 products highlights false equivalence claims on safety and efficacy, and Brazil faces a similar clinic-driven market—calling for ANVISA to tighten oversight, curb trademark misuse, and enforce compounding and dispensing rules.
2025
7
min read
Legal & Regulatory Updates
Legal & Regulatory Updates

Toward Leadership: How Brazil can Unlock Clinical Trials with Regulation, Transparency and Technology

Brazil can unlock leadership in clinical trials by pairing its new legal framework with clear implementing rules, better transparency tools, and technology integration—especially AI-enabled Real-World Evidence—while balancing IP protection and patient access.
2025
8
min read
Life Sciences & Healthcare Patents
Life Sciences & Healthcare Patents

ANVISA new rules allowing changes on marketing approval “waiting list”

ANVISA’s new 2025–2026 Operational Tactical Plan aims to reduce marketing approval backlogs by allowing applicants to replace pending submissions before formal review and by granting priority review for GLP‑1 receptor agonists.
2025
5
min read