Helping companies navigate regulated markets with confidence.
We combine international regulatory experience, technical expertise, and business insight to bring products to market more efficiently.
Why companies choose Sobel
Expertise that supports every regulatory step
We turn regulatory complexity into clear direction through technical depth and international experience.
International perspective
Experience across diverse markets and regulatory systems.
Regulatory strategy
Beyond documentation, we identify the most effective path for your product.
Multidisciplinary expertise
Regulatory, biological, clinical, quality, and documentation expertise working as one.
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.
FOUNDER & CEO
The vision behind Sobel
Sobel grew from Maik Endler’s experience across regulated industries, combining engineering, certification, consulting, and business leadership
This background shaped how our team works today: technically grounded, commercially aware, and focused on meaningful outcomes.
That cobination shaped the way our team works today: practical, technical and focused on helping clients make better decisions.
- Engineering
- Certification
- Quality
- Regulatory Affairs
OUR WAY OF THINKING
We don’t just follow regulations. We help you make better decisions.
Regulatory success begins with making informed choices from the start—not correcting gaps later.
Our approach combines scientific rigor, market insight, and strategic thinking to translate complex requirements into sound business outcomes.
Regulatory success is not about filling gaps—it’s about making the right choices from the start.
Our approach combines scientific rigor, practical insight, and strategic thinking to turn complexity into clarity and regulatory requirements into business outcomes.
We consider the broader context to align regulatory priorities with your business goals.
Decisions are grounded in science, data, and international regulatory standards.
Global Perspective
We connect local requirements with the realities of entering international markets.
Collaborative Partnership
We work alongside your team, sharing responsibility for progress and results.
OUR JOURNEY
From engineering expertise to international regulatory insight.
Our journey brings together engineering, industry experience, and regulatory leadership—shaping how Sobel works today.
Understanding how products are designed, manufactured, and perform in real conditions established the engineering foundation for everything that followed.
Leading manufacturing and quality operations developed a deep understanding of processes, compliance, and continuous improvement—connecting technical choices with business performance.
Sobel was founded to provide clear direction, technical depth, and close collaboration in highly regulated markets.
As its international work expanded, Sobel began supporting manufacturers across multiple markets and adapting each project to distinct regulatory environments.
Today, Sobel brings together engineers, regulatory specialists, and scientific experts to address complex challenges and advance healthcare innovation.
THE PEOPLE BEHIND SOBEL
Different expertise. One integrated team.
Our integrated team combines regulatory, scientific, operational, and client-focused expertise throughout each stage of a project.
Maik Endler
Founder & CEO
Michele Pimentel
Finance & Marketing
Camila Reis
Operacional Manager
Siliane Berte
Human Safety Coordination
Karina Marques
Regulatory Affairs Coordinator
Kaline Schroder
Sales Representative
Victoria Genesini
Biological and Clinical Safety Analyst
Diniara Munhoz
Human Safety Expert
Vanessa Sabino
Human Safety Expert
Priscila Ribeiro
Regulatory Affairs Expert
Thaynara Soares
Regulatory Affairs Expert
Rafaela Cavalcanti
Regulatory Affairs Expert
David Machado
IT Specialist
Every project brings together complementary expertise around one shared goal: turning technical challenges into measurable progress.
15+
Years of international
regulatory experience
200+
Projects successfully
delivered worldwide
99.2%
Approval sucess rate
Recognized by the industry
Healthcare Business Review LATAM featured Sobel for its work in highly regulated healthcare markets.
In the interview, Maik Endler discusses how technical expertise, commercial understanding, and informed planning can strengthen regulatory outcomes.
GLOBAL REACH
Regulatory expertise connected across markets.
We connect international experience with local knowledge to address the specific demands of each market.
