Our team of expert advisers focuses on providing a consistent story of safety and effectiveness, alignment between claims and evidence, and a submission architecture that lets them find answers quickly. Programs slow when testing is misaligned with claims, when labeling overreaches, or when sections contradict one another. Successful submissions show coherence across clinical and nonclinical evidence, human factors, cybersecurity, and manufacturing controls, supported by a plan for Interactive Review that preserves the logic of the file.
Different pathways place weight on different arguments. A 510(k), De Novo, PMA, or another submission type will each rely on its own evidentiary logic and required level of detail. The task is to match that logic to the product, keep the record inspection ready, and maintain tight version control so the device described in the file is the device on the bench and in the clinic. When these pieces align, reviews move faster and questions become easier to resolve.
Submissions designed for first-cycle success
- We map claims to the appropriate regulatory pathway and design a submission architecture that reflects how FDA reviewers work through the file.
- Our submission leads align test strategies, clinical evidence, human factors, cybersecurity, and manufacturing documentation so the narrative is internally consistent and defensible.
- We apply disciplined authoring, quality control, and version management to protect data traceability and to prevent updates from creating conflicts elsewhere in the record.
- During Interactive Review, we guide responses against an evidentiary plan, keep labeling and claims synchronized with the submission record, and maintain momentum toward a clear clearance or approval decision.
