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
• Submission Issue Request
• Investigational Device Exemption (IDE) Application
• Labeling and Promotional Supplement
• Supplement for Group Labeling of CDx
• Negotiating Therapeutic Approvals With or Without CDx

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
• Expertise in Genetic Tests, AAV Assays & Pharmacogenomics

As the integration of software and cybersecurity becomes increasingly critical in CDx devices, we offer specialised support to ensure your software meets FDA’s rigorous validation standards, including cybersecurity assessments.

• Software Validation Strategy and Execution
• Cybersecurity Risk Assessment and Mitigation
• Third Party Cybersecurity Testing Plan & Reports
• FDA Compliance for Software & Cybersecurity in CDx
• Documentation and Submission Support

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: Comprehensive QMS support, including corrective and preventive action (CAPA) plans, supplier management, and training.

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