Your Regulatory Compliance Experts

Specializing in regulatory expertise, Sobel helps you achieve compliance, reduce risk, and stay up-to-date across industries.

Medical Device Consultancy

We provide expert guidance in regulatory strategy, quality management, biological and clinical evaluation to help your medical device meet compliance requirements efficiently.

Cosmetic Consultancy

Navigate regulatory requirements with expert guidance. Our tailored approach helps you streamline compliance and successfully launch your products.

Expert Guidance for Medical Device Regulation

Navigating medical device regulations requires precision and expertise. We provide strategic guidance in regulatory compliance, submission processes, quality management, biological and clinical evaluations. We provide efficient, cost-effective solutions to help your medical devices meet compliance requirements. Partner with us for expert guidance at every stage of the process.

Cosmetic Compliance, Simplified

Regulatory challenges shouldn’t slow down your innovation. We help you navigate cosmetic regulations with confidence, providing expert support in product formulation, labeling, and packaging compliance. Whether launching a new line or expanding to global markets, our solutions lead your products to meet FDA, EU, Anvisa and international standards—so you can focus on growing your brand.

Latest article

Discover trends, tips, and expert insights to keep you ahead.

America

What is a US Agent for FDA registration and why is it essential for medical devices?

Entering the U.S. medical device market can be a major opportunity for international companies. However,

January 8, 2026

News

News: FDA Publishes Q3E for Extractables & Leachables

The FDA has published a new guideline aligned with ICH Q3E to support the assessment

December 19, 2025

Male hands holding a tablet. Graphic elements representing a Quality System.

News

News: FDA ISO 13485 harmonization and other regulatory updates

Check out the main regulatory news of the week, including FDA ISO 13485 harmonization via QMSR, Anvisa, and TGA.

November 21, 2025

Testimonial

Here is what our clients are saying about us

We’re satisfied with Sobel Consultancy’s regulatory services and support for our company because they tirelessly execute projects while taking all regulatory checkpoints into account to make sure that almost all activities are carried out ethical manner while achieving the maximum compliances and transparency, which is desired in all projects. Sobel Consultancy managed the entire project properly and delivered within the specified timelines, and we received permissions for our IVDs for the Brazilian market in a timely manner.

Lucas LewisMDS - Singapur

Thank you for all of your hard work and dedication. I’d want to highlight your work from the last weeks. Overall, the project result was fantastic, especially with all of the valuable tips and tricks. All of our previous supplier wouldn’t be able to handle such regulatory project with that complexity and quick turnover. Thanks!

Sophia GallagherTMX Medical - USA

I would like to personally thank you for your dedication and professional service. It’s the perfect solution for our business.

Emilia AndersonGWA Instruments - USA

As a client we have experienced a very friendly target oriented service with fast solutions. Looking very much forward to further projects.

Andreas KohlAndraTec

Sobel Consultancy was hired for a medical device registration project for one of our exported goods, and we secured the registration certificate well ahead of the company’s promised deadlines. The entire project was completed on time, professionally, and within our comfort zone. We are quite pleased with Sobel Consultancy’s entire performance and will happily suggest their services to anyone.

Abigail RiveraMedulha Surgical - Mexico