MORE THAN COMPLIANCE
Trust Growth Value
starts with regulatory strategy.
Regulatory decisions that strengthen your product, unlock markets, and build brand value.al, market access, and product growth.
International regulatory expertise
Brazil · United States · Canada · 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.
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.
Latest insights
Insights and updates to help you navigate compliance with confidence.
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.
News: Anvisa Regulatory Sandbox and Global Updates
Anvisa advances its Regulatory Sandbox initiative for personalized cosmetics while global regulators strengthen post-market surveillance.
News: FDA and AI-Powered Medical Devices
Learn more about the FDA’s regulatory framework for AI-powered medical devices and other global recent updates.
Biological Evaluation, Clinical, and Toxicological: What’s the Difference?
In the development and approval process of medical devices, three types of evaluations frequently appear
News: MDR/IVDR Revision and Unique Device Identification Codes in China
In addition to the MDR/IVDR review, unique device identification codes in China were given a final deadline. Learn more.
News: Alternatives for Cosmetic Animal Testing Gain Momentum
Alternatives for cosmetic animal testing advance with new FDA guidance and other global updates.
