What We Do
We Operationalize Science
At SciRegenix, we don’t create the science—we bring it to life.
We serve as the execution partner for early-stage drug and medical device programs that need structure, scientific leadership, regulatory rigor, and resource alignment to advance toward FDA approval and commercial acquisition.
Whether managing IP licensed through a client, supporting a university tech transfer office, or guiding an inventor’s first molecule through development, SciRegenix ensures that no great idea dies on the vine.
Drug Development Program Management
Full-scope operational oversight from discovery through IND and clinical transition, with milestone tracking and integrated vendor coordination.
Regulatory Strategy & FDA Submission Support
Development and execution of regulatory plans, including pre-IND meetings, IND filings, and designation applications (e.g., Orphan Drug, RPD).
Preclinical Study Oversight
Design, coordination, and management of IND-enabling studies—including toxicology, PK/PD, and GLP compliance—across qualified CROs.
Scientific & Technical Leadership
Alignment of scientific objectives with regulatory pathways, support for target product profile (TPP) design, and interpretation of preclinical data.
Commercial Readiness & Exit Packaging
Preparation of assets for licensing or acquisition, including data room assembly, competitive analysis, and deal support for strategic buyers.
Capital Deployment & Investor Reporting
Management of development capital with transparent financial oversight, investor updates, and milestone-aligned spending controls.
Team Assembly & Workforce Management
Custom staffing of expert scientific, regulatory, and project professionals tailored to each program’s unique needs.
University & Partner Engagement Support
Interface with tech transfer offices, academic inventors, and translational platforms to align development with licensing terms and institutional goals.
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