Helping companies navigate regulated markets with confidence.
We combine international regulatory experience, technical expertise, and practical business insight to help companies move products to market more efficiently.
Why companies choose Sobel
A strategic partner for every regulatory step
We help companies navigate regulatory complexity with clarity, technical depth, and a global perspective.
International perspective
Experience across different regulatory systems.
Regulatory strategy
We don’t just prepare documentation. We help define the smartest regulatory path.
Multidisciplinary expertise
Regulatory affairs, biological evaluation, clinical evaluation, quality and technical documentation working together.
Qualified multidisciplinary team
Our specialists bring expertise across regulatory affairs, quality management, biological and clinical evaluation, and technical documentation.
Clear, practical guidance
We help companies identify the right path, reduce risks, and move forward with greater confidence.
OUR JOURNEY
Building a global perspective to
deliver practical solutions.
We help companies navigate regulatory complexity with clarity, technical depth, and a global perspective.
Every solution starts with understanding how products are designed, manufactured and perform in the real world. This engineering mindset became the foundation of everything that followed.
Leading manufacturing and quality operations brought a practical understanding of processes, compliance and continuous improvement — where technical decisions directly impact business results.
Sobel was founded with a simple purpose: helping companies navigate regulated markets through practical guidance, technical depth and close collaboration.
As projects expanded internationally, Sobel evolved into a consultancy supporting manufacturers across multiple markets, adapting strategies to different regulatory environments.
Today, Sobel brings together engineers, regulatory specialists and scientific experts to help companies make better decisions, solve complex challenges and move their innovations forward.
THE PEOPLE BEHIND SOBEL
Differente expertise. One integrated team.
Our multidisciplinary team brings together regulatory, scientific, operational, and client success expertise to support every project—from strategy to successful market access.
Maik Endler
Founder & CEO
Michele Pimentel
Finance & Marketing
Camila Reis
Operacional Manager
Siliane Berte
Human Safety Coordination
Karina Marques
Regulator Affairs Coordinator
Kaline Schroder
Sales Representative
Victoria Genesini
Regulatory Analyst
Diniara Munhoz
Human Safety Analyst
Vanessa Sabino
Human Safety Analyst
Priscila Ribeiro
Regulatory Analyst
Thainara Soares
Regulatory Analyst
David Machado
IT Specialist
Rafaela Cavalcanti
Regulatory Analyst
Every project brings together complementary expertise with one common goal: helping clients make better decisions and achieve successful market access.
15+
Years of international
regulatory experience
200+
Projects successfully
delivered worldwide
95%
Successful approval rate
FOUNDER & DIRETOR
The vision behind Sobel
Sobel was built from Maik Endler’s experience working from multiple perspectives within regulated industries: engineering, certification, consulting and business leadership.
That combination shaped the way our team works today: practical, technical and focused on helping clients make better decisions.
That cobination shaped the way our team works today: practical, technical and focused on helping clients make better decisions.
- Engineering
- Certification
- Quality
- Regulatory Affairs
Recognized by the industry
Sobel was featured by Healthcare Business Review LATAM for its approach to regulatory strategy and market access in highly regulated industries.
The interview highlights Sobel’s approach to regulatory strategy, market access, and the importance of combining technical expertise with business understanding in complex healthcare environments.
GLOBAL REACH
Supporting companies in highly regulated markets around the world.
We combine international regulatory expertise with local insight to provide reliable guidance and practical solutions, wherever you are.
