U.S. Food & Drug
Administration
Submission Support
Navigating FDA submissions with experts in regulatory compliance.
About Us
Simaia LLC is a specialized consulting firm founded by former FDA staff specializing in regulatory review of 510(k), De Novo, PMA, and Breakthrough Device submissions. We are experienced Scientific Reviewers, Bioinformaticians, and Computer Scientists, integrating expertise, advanced algorithms, and AI into regulatory support services.
Our Services
Our team ensures compliance with evolving FDA requirements by applying technical precision and domain-specific knowledge.
Cybersecurity documentation in accordance with Section 524B of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
Software and firmware documentation as outlined in FDA guidance
Next Generation Sequencing (NGS)-based device submissions
Human microbiome-based device submissions
Contact for Inquiries
Reach out to our expert team for assistance with FDA submissions and regulatory guidance tailored to your needs.
Support
support@simaia.xyz
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