Regulatory Affairs & Product Registration
End-to-end regulatory affairs, development strategy and registration management, with practical evidence pathways for major markets including China, the United States and Europe.
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ORIVITY BIOTECHNOLOGY
Advancing Innovation in Companion Animal Health
With a global animal health industry perspective and veterinary clinical expertise, we provide services spanning development strategy, clinical evidence, regulatory registration and business collaboration.
Orivity Biotechnology focuses on the development and translation of innovative companion animal therapeutics. We provide global, actionable support in R&D strategy, regulatory registration and clinical development.
Our core team brings decades of animal health R&D experience, having led or contributed to dozens of global drug development programs, clinical trials, regulatory submissions and agency interactions. The team also has extensive experience in translational animal model research at leading universities and research institutions.
Explore our capabilitiesEngage us for end-to-end program support or focused expertise at a specific stage, according to your pipeline and project needs.
End-to-end regulatory affairs, development strategy and registration management, with practical evidence pathways for major markets including China, the United States and Europe.
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Protocol design, site coordination, execution support and evidence integration across proof-of-concept studies, investigator-initiated trials and GCP clinical trials.
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Pipeline representation, opportunity screening, value assessment, licensing outreach and partnership advancement for animal health assets.
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Gap assessment, quality system development, documentation and accreditation preparation for AAALAC and CNAS animal research facilities.
Discuss a project →We address long-term unmet needs associated with aging and chronic disease while supporting innovative therapies that advance comparative medicine.
Clarify product positioning, indication, target markets and critical risks.
Evaluate safety and efficacy through POC, IIT and well-designed clinical studies.
Coordinate technical documentation, agency interactions and submission milestones.
Connect development programs with manufacturing, licensing and commercialization resources.
We welcome conversations with biopharma companies, research teams, investors and industry partners.