Our solutions
At Sobel Consultancy, we deliver tailored regulatory solutions, including compliance audits, risk assessment, policy development, and training. Our expert guidance ensures your team stays informed and compliant, helping you navigate regulations and reduce risks effectively.
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Regulatory Compliance Solutions for the U.S. Cosmetic Industry
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) updates FDA oversight, enhancing safety for everyday cosmetics. It mandates facility registration, product listing, adverse event reporting, and Good Manufacturing Practices (GMP). MoCRA grants the FDA new powers for accessing safety records and enforcing recalls, ensuring safer, compliant products and fostering consumer trust.
Our Services in Regulatory Compliance Solutions
Regulatory expertise to help you navigate Anvisa requirements with confidence. Explore the key steps of the registration process for medical devices and how Sobel can support you.
Pre-Registration Setup
Risk & Safety Assessment
Clinical and Safety Evaluations
Documentation & Submission
Post-Submission Compliance
Regulatory Affairs Support
Navigate regulatory affairs with our service, ensuring compliance with RDC 751/2022.
Quality Management Support
Align your QMS with RDC665/2022 through expert support in audits, processes & standards.
Risk Management
Manage device risks with ISO14971 support, including risk analysis and control measures.
Biological Evaluation
Complete Biological Evaluation for devices, aligned with ISO10993 for safety & compliance.
Clinical Evaluation
Clinical Evaluation aligned with Guia nº 31/2020, ensuring device safety and performance.
Submission File Elaboration
Prepare a robust technical dossier aligned with RDC 751/2022, supporting market approval.
Toxicological Risk Assessment
Toxicological risk assessment aligned with RDC546/2021, mitigating risks for market entry.
Brazilian Registration Holder
Navigate market access in Brazil with Sobel as your device registration holder.
Training
Tailored training in RDC 751/2022, MDR 2017/745, and device toxicological evaluations.
Entering the Brazilian medical device market requires a solid understanding of Anvisa regulations and a clear regulatory strategy. Our team helps you navigate RDC No. 546/2021 and RDC No. 751/2022 to meet all requirements.
We assist with accurate submissions, anticipating potential regulatory challenges and streamlining documentation. Our risk assessments, aligned with ISO 10993 standards, evaluate biological, clinical, and toxicological risks to help ensure your product’s safety.
We guide you through preparing technical dossiers that comply with Anvisa’s standards. We also provide ongoing support to manage post-market obligations, adapt to regulatory updates, and maintain compliance smoothly.
Whether launching a new product or expanding your presence in Brazil, we provide the strategic support you need to move forward confidently.
Latest article
Discover trends, tips, and expert insights to keep you ahead.
EU Cosmetics Regulation: Complete Guide to Registering Your Products
Learn how to register cosmetic products under the EU Cosmetics Regulation. Ensure compliance and safe market entry in the European Union!
Medical Device Internal Audit: Key Steps and Best Practices
Explore the essential steps and best practices for conducting an internal audit of medical devices. Ensure compliance with expert tips!
Understanding MoCRA: FDA Compliance for Cosmetics in the USA
Learn how the Modernization of Cosmetics Regulation Act (MoCRA) transforms industry standards and how to achieve FDA compliance.
