FDA submissions

Biologics Consulting is an FDA regulatory affairs and product development consulting firm founded in 1993 by former FDA officers as a fully employee-owned (ESOP) company. It provides integrated multidisciplinary regulatory strategy and operations support for biologics, pharmaceuticals, medical devices, and combination products, with 30+ years of history, 4700+ projects, and clients in 58+ countries.

biostatistics consultationclinical developmentCMCFDA meeting preparationnonclinical pharmacology/toxicologyquality systems & trainingregulatory operationsregulatory strategyStaff augmentation

CAHIR Solutions is a woman-owned small business registered and certified with the State of Florida, SBA, and Sam.gov. It partners with MedTech, life sciences, and public sector leaders to navigate regulatory pathways, generate defensible evidence, and modernize with AI. Its three integrated practices help turn innovation into a defensible, scalable business, with engagements led by senior strategists experienced in FDA submissions, federal evaluations, and AI deployments in regulated environments.

AI/ML integrationautomationcomplianceevaluation analyticsfederal evaluationsregulatory pathway navigation

Compliance Insight is an FDA regulatory and quality compliance consulting firm serving the life sciences industry. It helps businesses overseen by the FDA navigate the regulatory process, achieve compliance, and develop best practices for manufacturing drugs, medical devices, and biologics. Its specialists each offer at least 15 years of industry experience, and the firm has assisted hundreds of clients across North America and globally.

auditsCAPA plan developmentelectronic publishingFDA 483 / Warning Letter responseFDA compliance consultinggap analysisGCP servicesGMP servicesinspection preparationmock inspectionsproject managementquality systemsregulatory affairs trainingregulatory strategiesroot cause analysisStaff augmentationvirtual quality assurance

CovarsaDx is a boutique contract research organization (CRO) specializing exclusively in in vitro diagnostic (IVD) and medical device clinical research. It provides full-service clinical research including trial support, regulatory consulting, and quality assurance, helping sponsors navigate FDA pathways such as 510(k), De Novo, PMA, and EUA from study design to regulatory approval.

clinical study designclinical trial managementquality assuranceRegulatory consulting

CUBE Medical Innovations, Inc. is a medical device product development and management company founded in September 2014 by Kelly Elliott and Chuck Walker. It helps physician inventors and innovators take a device concept from idea through design, manufacturing, and commercial launch, following FDA regulations and ISO 13485 design and development compliance.

CAD modelingclinical trainingcybersecurity for electronic devicesdesign controlsFMEA risk analysisISO 13485 regulatory submissionsmanufacturing process validationmanufacturing scale-upmedical device product developmentprototyping