Strategic regulatory consulting to move your product forward

We support medical devices, IVDs, and cosmetics companies with regulatory strategy, compliance, and submissions — helping you navigate complex requirements with clarity and confidence.

Explore our solutions

Regulatory consulting for medical devices, IVDs, and cosmetics

Medical Devices

Regulatory support for medical devices, with expertise in biological and toxicological evaluations and lifecycle regulatory consultancy.

Brazil

Cosmetics

Regulatory support for cosmetics, combining representation services with labeling & claims review and more for compliant market entry.

In Vitro Diagnostics

Regulatory support for IVD companies, acting as Registration Holder and assisting with notification and registration across multiple regulatory frameworks.

Brazil

Regulatory solutions designed to guide your next steps

Regulatory Strategy & Market Access

Strategic regulatory consulting to define the most appropriate pathway for market entry, considering product classification, target markets, and regulatory requirements.

Representation Services

Representation services to support structured communication with regulatory authorities, including submissions follow-up, responses to authority requests, and liaison activities.

Biological & Toxicological Evaluation

Scientific and regulatory consulting for biological safety and toxicological assessments, supporting risk evaluation and regulatory justification.

Labeling, Claims & Compliance Review

Regulatory review of labeling, claims, and product information to ensure alignment with market-specific regulatory expectations.

Quality Management Systems (QMS)

Consulting support for quality management systems aligned with regulatory and standard requirements, supporting compliance, audits, and ongoing quality activities.

Regulatory Training

Structured regulatory training programs designed to build internal capability, strengthen regulatory understanding, and support informed decision-making across teams.

Sobel provides structured guidance aligned with each regulatory context.

Who trust us

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