Professional and Experienced FDA Guidance
Expert guidance for medical device FDA approvals, including 510(k), De Novo, PMA, and IDE submissions for all companies.
FDA Submission Guidance
At GreenLight Preclinical Planning, we provide specialized advice to medical device companies, simplifying the complex FDA regulatory process. We offer specialty expertise in the preclinical planning phase of 510(k), de novo, PMA, and IDE submissions.
Protocol Development and Study Design
We specialize in developing comprehensive scientific protocols for preclinical animal studies, specifically designed for the rigorous evaluation of medical devices. Our protocols are meticulously crafted to meet the specific needs of both in vivo and ex vivo testing, ensuring every detail from study design and animal model selection to data collection and analysis is covered. By integrating a deep understanding of FDA regulatory requirements and ethical considerations, we ensure that your study is not only scientifically sound but also poised for regulatory success. Our goal is to provide a robust framework that supports the safety and efficacy of your medical device, streamlining its path toward market approval.
Regulatory Strategy
We offer expert regulatory strategy services to guide your medical device through the complex FDA approval process.
Our experience includes preclinical-oriented pre-submissions, preclinical study data review and analysis, and deficiency responses.
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