Navigating the FDA submission process can be daunting, but our expertise ensures a smooth and expedited journey. We offer end-to-end support, from preparing QMS documents, regulatory submission documents to communicating with the FDA on your behalf, with a focus on achieving the least burdensome submission.

• Breakthrough Device Designation Application
• Premarket Approval (PMA), DeNovo, or 510(k) Submission
• Solicitação de emissão de envio
• Isenção de dispositivo de investigação (IDE) Aplicação
• Rotulagem e suplemento promocional
• Suplemento para rotulagem em grupo de CDX
• Negociação Aprovadores terapêuticas com ou sem CDX | A validade clínica e analítica do seu CDX é essencial para obter a aprovação do FDA. Nossa equipe é especializada em apoiar estudos de verificação e validação, otimizando-os para obter resultados rápidos com carga mínima. Estratégia

Ensuring the clinical and analytical validity of your CDx is key to gaining FDA approval. Our team specialises in supporting verification and validation studies, optimising them for fast-track results with minimal burden.

• Study Design Consultation (such as Accuracy, Precision, Interference, etc.)
• Study Design with Least Number of Clinical Samples
• Data Analysis and Interpretation
• Study Reports & Summaries
• Sample Selection Strategy
• experiência em testes genéticos, ensaios de AAV e farmacogenômica

Como a integração de software e cibersegurança se torna cada vez mais crítica em dispositivos CDX, incluindo o suporte especializado para garantir que o seu software atenda aos padrões rigorosos da FDA. Execução

• Software Validation Strategy and Execution
• Avaliação e mitigação de risco de segurança cibernética
• Plano e relatórios de teste de segurança cibernética de terceiros
• Conformidade FDA para software e cibersegurança em CDX
• Documentação e suporte de submissão

A strong Quality Management System is essential for CDx device compliance. We provide comprehensive support across all phases of product development, ensuring alignment with FDA regulations and industry standards for a streamlined and fast-tracked pathway to market.

• Feasibility Testing and Early Development: Guidance on feasibility assessments and early-stage development processes to set the foundation for success.
• Development and Verification: Support for assay development, and documentation including robust verification processes that meet FDA requirements.
• Validation: Assistance with analytical and clinical validation studies documentation, ensuring compliance with FDA standards while minimizing regulatory burden.
• Risk Analysis: Expertise in the mentoring teams to conduct risk analysis for devices and therapeutics with focus on false negative and false positive results.
• Operations: Expertise in the transfer of validated assays to operational settings, ensuring seamless transition and scalability for commercial use.
• Commercial Use: Post-market compliance and surveillance to support your device throughout its lifecycle.
• QMS Implementation and Auditing: Suporte abrangente ao QMS, incluindo planos corretivos e preventivos de ação (CAPA), gerenciamento de fornecedores e treinamento. Fornecemos suporte contínuo para ajudá-lo a navegar nos requisitos pós-mercado e garantir que seu dispositivo permaneça compatível com um olho nos processos simplificados que continuam a reduzir a carga. Suporte

Maintaining compliance doesn’t end at approval. We provide ongoing support to help you navigate post-market requirements and ensure your device remains compliant with an eye on streamlined processes that continue to reduce burden.

• Post-Market Surveillance Strategies
• Adverse Event Reporting
• Periodic Reporting and FDA Communications
• Label Changes and Re-Submissions with Fast-Track Support