Expertise for every
regulated product.
Solutions for every
markt.
Turn compliance challenges into strategic actions that support approval, market access, and product growth.
Choose your industry to explore our solutions
Medical Devices
Strategic regulatory support for medical devices, active devices and software, from development through global market access.
Cosmetics
Regulatory support for cosmetic products, including safety assessment, labeling review and market compliance.
In vitro
Specialized regulatory guidance for IVD products, from registration and technical review through post-market compliance.
Medical Devices
Strategic regulatory support for medical devices, active devices and software, from development through global market access.
Cosmetics
Regulatory support for cosmetic products, including safety assessment, labeling review and market compliance.
CLIENT VOICES
Trusted for decisions that move products forward.
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Fast solutions, focused on your goals
“Sobel provided a friendly, goal-oriented service with fast solutions. We look forward to working together on future projects.”
Andreas Kohl
CEO · Andratec
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Broad expertise, real collaboration
“I experienced always supportive, pro-active collaboration from Sobel Consult with high degree of competency in broad regulatory range.”
Mandy Blocher
Expert Regulatory Framework & Digital Transformation · Aesculap AG (B. Braun)
Clear regulatory direction
The right pathway and priorities for your product.
Fast and responsive support
We act quickly to keep projects moving.
Practical guidance
Actionable advice for your next step.
Latest insights
Insights and updates to help you navigate compliance with confidence.
Product rejected by ANVISA: what now?
A rejection is not the end of your product in Brazil. See the two paths, the 30-day appeal deadline and what to do before filing anything.
ANVISA technical requirement: how to answer without triggering a rejection
A technical requirement is a chance to complete your application, not a refusal. The 120-day deadline, why answers fail and how to structure a strong one.
Slow ANVISA review: what is normal and what signals a problem
Part of the wait is normal. How to tell queue from problem, why a missed technical requirement is the biggest risk and what to do while you wait.
