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CaleByte Health & Innovations

Services

Expert support for every stage of health innovation

From regulatory strategy and AI validation to clinical research operations, we help partners move from ambition to evidence to impact.

Advisory & innovation

Advisory services

Strategic and technical expertise for organizations developing, regulating, or adopting health innovations.

Regulatory & Compliance Advisory

Navigate FDA, EFDA, and WHO expectations with clear regulatory mapping, compliance readiness, and governance support.

  • FDA, EFDA, and WHO regulatory mapping
  • Compliance readiness
  • Regulatory documentation
  • Policy development
  • Ethics and governance advisory

AI Health Solutions & Testing

Advisory, validation, and testing services that help AI health tools perform safely, fairly, and reliably for the people they serve.

  • Health chatbot advisory
  • AI model validation support
  • AI bias testing
  • Safety testing
  • Functional testing
  • Usability testing

Consulting & Roadmapping

Strategy, scoping, and pilot planning that turn health innovation ideas into practical, IRB-ready programs and technology roadmaps.

  • AI integration strategy
  • Product scoping
  • Pilot planning
  • IRB-ready design support
  • Technology roadmapping

Capacity Building

Workforce, institutional, and regulatory capacity strengthening that leaves research and health systems stronger long after a project ends.

  • Research workforce development
  • Institutional readiness
  • Regulatory capacity strengthening
  • Research operations improvement

Calebyte BioSolutions

Clinical research services

Our contract research organization supports sponsors conducting clinical research in African populations.
Explore Calebyte BioSolutions

Not sure where to start?

Tell us about your goals. We will help you identify the services and approach that fit.