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At RIAR Consulting, we provide comprehensive regulatory support and strategic guidance for manufacturers and distributors looking to enter or expand in key global markets. Our services are designed to simplify complex regulatory processes, ensure compliance, and accelerate time-to-market for medical devices, in-vitro diagnostics (IVDs), cosmetics, and other regulated products.
RIAR Consulting specializes in navigating the Saudi Food and Drug Authority (SFDA) regulatory landscape. We provide end-to-end support, including product classification, technical file preparation, application structuring, submission management, and post-market compliance. Our dedicated SFDA consultants ensure high approval success rates while keeping your products compliant with local regulations.
Entering the U.S. market requires strict adherence to the FDA’s rigorous standards. RIAR Consulting helps clients prepare and submit 510(k), PMA, and other regulatory filings, ensuring conformity with FDA requirements. From documentation review to risk management and labeling compliance, we facilitate smooth market entry and regulatory approval.
The EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) demand precise technical documentation, risk assessment, and conformity evaluation. RIAR Consulting assists in preparing EU-compliant technical files, coordinating with Notified Bodies, and maintaining post-market surveillance systems, helping our clients achieve timely CE marking and market access.
Following Brexit, the UK has its own regulatory framework under the Medicines and Healthcare products Regulatory Agency (MHRA). RIAR Consulting guides clients through UKCA marking, registration, and compliance requirements. We ensure your products meet local standards while maintaining alignment with international regulations.
For companies targeting the Indian market, RIAR Consulting offers complete support for Central Drugs Standard Control Organization (CDSCO) registration. We handle product classification, documentation, application submission, and regulatory follow-ups, helping clients navigate India’s evolving regulatory landscape efficiently.
Beyond these primary markets, RIAR Consulting provides strategic regulatory advice and compliance support for other global regions. Leveraging our network of experienced regulatory consultants worldwide, we help clients align with local requirements, manage international submissions, and maintain consistent quality standards across markets.
Let’s collaborate to shape a future where opportunities are limitless.
Stay informed with RIAR Consulting as we share key regulatory updates, compliance insights, and global market access guidance.Your trusted partner for efficient approvals across SFDA, US FDA, EU, UK, and India.
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