Cristina Giachetti
- Role
- Founder and Principal Consultant at Advantdx
- Location
- San Diego, US
- LinkedIn followers
- 500 followers
About Cristina Giachetti
An accomplished life sciences R&D executive with a recognized track record of successful…
Experience
Founder and Principal Consultant
Jun 2018 — Present
AdvantDx provides comprehensive expert advice and contract consulting services for medical diagnostics product development and commercialization, specializing in R&D strategy, planning and execution. Primary clients are innovators of technologies applicable to diagnostics, startup companies that currently do not have the full product development expertise or bandwidth to include full time in house experts, and more established companies in need of extra resources for particular projects. AdvantDx assists clients with technology assessment, the translation of technologies into product concepts, design control documentation, definition of product requirements, clinical and regulatory strategy and submissions (pre-Sub, IND, 510K, PMA, BLA, WHO-PQ, CE, etc.), focusing on intended use definition, analytical V&V studies and clinical trial design, and with the planning of the tasks required for efficient development and commercialization worldwide. Cristina Giachetti’s extensive experience developing diagnostics and blood screening products helps organizations mitigate risks, avoid mistakes and corresponding delays. Her deep understanding of the impact of FDA and CLIA regulations on product development and commercialization, and her broad expertise overseeing key company functions provides an integrated perspective to accelerate development and commercialization.
Education
UC Irvine
Post Doctoral Fellow, Molecular Virology
1987 — 1991
UC San Diego
Post Doctoral Fellow, Virology
1985 — 1987
University of Buenos Aires
Biochemist, Clinical Diagnosis
1972 — 1978
University of Buenos Aires
Doctor of Philosophy (Ph.D.), Biochemistry
1979 — 1985
Skills
- Medical Devices
- Mentoring
- Strategic Planning
- Scientific Presentations
- Leadership
- Infectious Diseases
- Technology Transfer
- Ce Marking
- Biotechnology
- Team Building
- V&V
- Technology Feasibility
- Clinical Trials
- Product Development
- Regulatory Submissions
- Product Launch
- Scientific Collaborations
- Cross-Functional Collaborations
- Manufacturing Transfer
- Design Control
- Diagnostics
- Innovation
- Fda, Cber, Cdrh
- Publications
- Oncology Markers
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