Regulatory Intelligence
Our Regulatory Intelligence as a Service (RIaaS) provides comprehensive support to ensure your compliance with evolving regulations. We monitor changes, analyze impacts, offer tailored guidance, and provide training to navigate complexities and reduce risks, ensuring your products meet regulatory standards for successful market entry.
CDCSO Approvals
We assist in obtaining approvals from the Central Drugs Standard Control Organization (CDSCO), ensuring your medical devices comply with Indian regulatory standards, facilitating market access and regulatory compliance.
We provide comprehensive support for obtaining CE marking for your medical devices, ensuring compliance with European regulatory requirements and enabling market access in the EU and other CE-mark accepting countries.
QMS Implementation
Implementing Quality Management System (QMS) as per ISO 13485. Our service ensures your organization meets international standards for medical devices, enhancing product quality, regulatory compliance, and customer satisfaction
FDA PMA
Our service supports companies in preparing and submitting Premarket Approval (PMA) applications to the FDA for high-risk medical devices, ensuring compliance with regulatory requirements and facilitating market approval in the United States.
Elevate Your Strategy with our Regulatory Intelligence Services
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Regulatory Monitoring: We keep a close eye on regulatory changes and updates, providing timely alerts and notifications to ensure you stay informed.
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Impact Analysis: Our experts analyze regulatory changes to understand their implications for your products, processes, and business, helping you make informed decisions.
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Compliance Guidance: We offer expert guidance on how to comply with regulatory requirements, including best practices and strategies for achieving and maintaining compliance.
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Customized Solutions: We tailor our services to meet your specific needs, taking into account your industry, products, and regulatory environment.
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Training and Education: We provide training programs and educational resources to help you understand and implement regulatory requirements effectively.
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Risk Management: We assist you in identifying and mitigating regulatory risks, ensuring a smooth path to compliance.
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Audit Support: We support you during regulatory audits, including preparation, documentation
Regulatory Path Made Easy: Simplifying Compliance for Your Success.
Navigating the regulatory path can be complex and challenging, often requiring a deep understanding of ever-changing regulations and standards. At L2D Health care, we specialize in making this journey easier for you. Our team of experts stays abreast of the latest regulatory updates and insights, providing you with tailored guidance to streamline your compliance process. We offer comprehensive support, from initial assessment to final submission, ensuring that your products meet all regulatory requirements. With our simplified approach, you can navigate the regulatory path with confidence, knowing that you have a trusted partner by your side, dedicated to your success.