YOUR CHALLENGES

Maybe you tried to expand your business through product registration in your or a foreign market. But with limited sucess. You are facing the following challenges:

  • You don't know the regulatory requirements and culture of your markets?

  • You don't have the right qualification inhouse?

  • Your company is still small and needs to focus their resources on growth?

  • Established consultants are expensive and lack of modern tools?

We can support you through our team of experts and unique business model to overcome these challenges.

That you can focus on what matters most - your business growth.

OUR SOLUTIONS

Regulatory Compliance

In 3-steps to a compliant
product documentation

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Quality Management

Procedures that suit your
business

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Local Representative

A reliable partner at your
side

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Market Access

Brazil

Europe

99.4%

Customer satisfaction rate

119

Years of experience

98.4%

Projects completed on time

TESTIMONIALS

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

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Emilia Anderson

GWA Instruments – USA

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.

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Lucas Lewis

MDS – Singapur

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.

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Abigail Rivera

Medulha Surgical – Mexico

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!

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Sophia Gallagher

TMX Medical – USA

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

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Andreas Kohl

AndraTec – Germany