Skip to content
777 Sourcing.

Capability

FDA submission review

Suppliers
2
States & provinces
2
Countries
1

2 fda submission review suppliers across 2 states and provinces in 1 country. Profiles show capabilities, materials, certifications, and facility locations so you can compare shops and build a shortlist.

Suppliers

DEFFAI, INC.

SAN JOSE, CA

Deffai provides AI-assisted regulatory intelligence validated by former FDA reviewers. The company is built by former FDA reviewers and decision-makers across CBER, CDER, and CDRH with 100+ years of experience across cell & gene therapy, including mRNA, AAV, ADC, immunotherapies for vaccines, oncology, regenerative medicine and tissue engineering for medical device and combination products. Deffai is an independent firm and is not affiliated with the U.S. Food and Drug Administration.

AI-assisted regulatory assessmentFDA meeting representationregulatory strategy

Compiled from public sources

INOVECTRUM, LLC

BOYDS, MD

Inovectrum is a specialist technology practice focused on connectivity for medical devices and clinical environments. It provides specialist consulting and collaborative R&D for medical device connectivity and connected healthcare systems, integrating device architecture, network behavior, electrical safety, EMC, interoperability, cybersecurity, regulatory science, and engineering evidence. The practice serves medical device organizations, healthcare institutions, research sponsors, universities, standards groups, and technology collaborators.

collaborative R&DCybersecuritydeficiency responseelectrical safetyEMC evaluationinteroperabilitymedical device connectivity consultingQ-Submission supportregulatory strategysystem integrationtest strategy development

Compiled from public sources

Related capabilities

Other processes offered by the shops that list FDA submission review.

Browse all capabilities