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Global Experience at your finger tips
United States
Streamlining FDA submissions (510(k), IDE/PMA, IND, NDA, BLA) and ensuring eCTD compliance: Regal Intel streamlines your pathway to US market access, offering expert guidance through the complexities of FDA submissions. From 510(k) clearances and IDE/PMA approvals for medical devices to IND, NDA, and BLA applications for pharmaceuticals and biologics, we ensure meticulous preparation and submission. Our deep understanding of eCTD requirements ensures your documentation meets the highest standards, accelerating your approval timeline and minimizing regulatory hurdles.
Europe
Comprehensive support for EU MDR, IVDR, CTA, and IMPD requirements for seamless EU market entry.: Navigate the evolving European regulatory landscape with confidence. Regal Intel provides comprehensive support for Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) compliance, as well as Clinical Trial Applications (CTA) and Investigational Medicinal Product Dossiers (IMPD). We guide you through the intricacies of EU regulations, ensuring your products meet stringent requirements and achieve seamless market entry throughout the European Union.
Asia Pacific
Latin America
Tailored solutions for navigating diverse regulatory frameworks in China (NMPA), Japan (PMDA), Korea, Singapore, Australia (TGA), and New Zealand.: Expand your reach into the dynamic Asia-Pacific market with Regal Intel's specialized regulatory expertise. We provide tailored solutions for navigating the diverse regulatory frameworks of China, Japan, Korea, Singapore, Australia, and New Zealand. Our in-depth knowledge of local requirements and submission processes ensures your products gain timely approvals, enabling you to capitalize on the region's vast market potential.
Latin America
Global Policy Creation
Latin America
Strategic guidance for market entry in Mexico, Brazil (Anvisa), Argentina, Costa Rica, Chile, and other key LATAM countries.: Unlock the growing Latin American market with Regal Intel's strategic regulatory guidance. We assist you in navigating the unique regulatory landscapes of Mexico, Brazil, Argentina, Costa Rica, Chile, and other key Latin American countries. Our expertise in local regulations and submission requirements ensures your products achieve swift and compliant market entry, enabling you to establish a strong presence in this expanding region.
Global Policy Creation
Global Policy Creation
Global Policy Creation
Developing robust global regulatory policies, conducting risk assessments, and creating documentation aligned with international standards (e.g., ICH) for consistent compliance worldwide.: Regal Intel empowers your organization to establish robust global regulatory policies that ensure consistent compliance across diverse markets. We collaborate with you to develop tailored strategies, conduct thorough risk assessments, and create comprehensive documentation that aligns with international standards. Our proactive approach helps you anticipate regulatory changes, mitigate risks, and build a strong foundation for sustained global success.
Biotech Consulting
Global Policy Creation
Global Policy Creation
Providing up-to-date intelligence on global regulatory changes to inform strategic decision-making.: Join our vibrant community of regulatory professionals to stay ahead in the ever-evolving landscape of global compliance. Connect with industry experts, access exclusive resources, and engage in meaningful discussions on the latest regulatory trends. Share best practices, gain valuable insights, and build strategic partnerships that drive your success. Become part of a network that empowers you to navigate regulatory complexities with confidence.