Brazilian OTC Product Registration Services
Over-the-Counter (OTC) products in Brazil must comply with ANVISA’s RDC 98/2016, which outlines specific requirements for labeling, packaging, and registration. At Hegemoni Regulatory & Business Solutions, we provide Brazilian OTC Product Registration Services, guiding clients through the less intensive but mandatory regulatory processes to ensure compliance. Our expertise ensures your products meet ANVISA’s standards for safe and effective consumer access.
What We Do:
Our OTC product registration services are designed to simplify compliance with ANVISA’s regulatory framework. These services include:
- Regulatory Assessment: Evaluating your product to determine its eligibility for OTC registration under RDC 98/2016.
- Documentation Preparation: Assisting with the preparation of technical dossiers, product information, and safety data for submission.
- Labeling Compliance: Designing and reviewing product labels to meet ANVISA’s transparency, safety, and consumer information requirements.
- Registration Filings: Managing the application process and liaising with ANVISA to secure approvals.
- Ongoing Compliance Support: Monitoring regulatory updates and ensuring continued compliance for existing OTC products.
By handling the complexities of registration, we ensure your OTC products are market-ready and fully compliant with Brazilian regulations.
How We Add Value:
At Hegemoni Regulatory & Business Solutions, we streamline the OTC product registration process, reducing risks of delays or rejections. Our tailored solutions ensure your products meet all regulatory requirements, providing safe and effective access for Brazilian consumers.
Why Choose Hegemoni Regulatory & Business Solutions?
With extensive experience in ANVISA regulations and OTC product registration, we have successfully supported clients across the consumer healthcare industry. Our personalized approach ensures your products comply with legal standards while fostering trust and accessibility in the Brazilian market.
Take the Next Step:
Schedule a Free Consultation:
Ready to register your OTC products in Brazil? Visit our Contact Page to schedule a free consultation with our team today! Let us help you navigate ANVISA’s registration process under RDC 98/2016 and ensure compliance with regulatory standards.
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