MORE THAN COMPLIANCE
Regulatory strategy for medical devices cosmetics in vitro diagnostics
Decisions that strengthen your product and open markets in Brazil, the US, Canada and Europe
Find your regulatory path
Start with your product. We’ll help define the right market and regulatory pathway.
Medical Devices
Strategic regulatory support for medical devices, active devices and software, from development through global market access.
Cosmetics
Regulatory support for cosmetic products, including safety assessment, labeling review and market compliance.
In Vitro Diagnostics
Regulatory consulting for in vitro diagnostics, from classification and performance evaluation to global market access.
STRATEGIC & SCIENTIFIC CAPABILITIES
Regulatory decisions require more than submissions.
We combine regulatory strategy, scientific evidence, and market expertise to guide confident decisions at every stage of development.
Regulatory Strategy & Gap Assessment
Biological Evaluation
Clinical Evaluation
Toxicological & Safety Assessment
Trusted for decisions that move products forward.
Clear regulatory direction
We identify the right pathway and priorities for your product.
Fast and responsive support
Our team acts quickly to keep your projects moving forward.
Practical guidance for the next step
Actionable advice tailored to your challenges and goals.
Why companies choose Sobel
Expertise that supports every regulatory step
We turn regulatory complexity into clear direction through technical depth and international experience.
International perspective
Experience across diverse markets and regulatory systems.
Regulatory strategy
Beyond documentation, we identify the most effective path for your product.
Multidisciplinary expertise
Regulatory, biological, clinical, quality, and documentation expertise working as one.
Latest insights
Insights and updates to help you navigate compliance with confidence.
News: ISO 10993-1:2025 Is Now ABNT NBR – What It Means for ANVISA
ISO 10993-1:2025 is now ABNT NBR in Brazil. See what changes in biological evaluation for ANVISA registration.
EUDAMED Deadline 2026: What to Do Before 27 November
Your devices have been on the EU market for years. They have valid certificates, a
FDA and Generative AI-Enabled Medical Devices: What the 2026 Discussion Paper Signals for Manufacturers
Generative AI medical devices are moving into a new regulatory phase. In its 2026 discussion
ANVISA Changes Cosmetic Petition Procedures: New Codes Take Effect September 1, 2026
ANVISA has introduced a new petition structure for requests involving substances, functions, packaging and physical
Innovative Medical Devices in Brazil: How ANVISA’s 2026 Pilot Program Works
ANVISA has opened a new opportunity for manufacturers of innovative medical devices seeking a clearer
RDC No. 1,030/2026: ANVISA Updates the List of Prohibited Substances in Cosmetics
Understand how ANVISA’s RDC No. 1,030/2026 may impact cosmetic formulations, product portfolios, and regulatory compliance deadlines in Brazil.
