Clear scope, acceptance criteria agreed up front, and deliverables your team can maintain.
Every engagement is scoped to a defined deliverable, with the acceptance criteria agreed before work starts.
A fixed-scope review with a written readout: a data integrity or Part 11 gap assessment, a method transfer readiness review, a CMC gap assessment, or an audit of an analysis pipeline.
A defined build or analysis: a flow cytometry analysis workflow, a method comparison or stability analysis, a QC dashboard, a validation package, or a set of SOPs.
Ongoing access for teams that need an analytics and quality perspective on call: reviewing analyses, protocols, and reports, and preparing for inspections or agency meetings.
Cell and gene therapy developers, including autologous CAR-T and iPSC-derived programs, plus biologics, cell products, CROs, and IVD teams working under GMP, GLP, and 21 CFR Part 11.
Yes. A confidentiality agreement is standard before any data or documents are shared.
Data stays in the environment agreed in the written scope: your systems, or a de-identified extract. Nothing is kept after the engagement unless the scope says otherwise.
Only with your written approval, and never with confidential or identifiable data in a public tool. Anything AI contributes gets documented human review, the same standard applied to any other input.
Deliverables are built to GxP expectations and to your SOPs. Your quality unit keeps approval authority, as it should.
Yes. That includes validated systems such as Veeva Vault, LIMS, and ELN, within the access and training your procedures require.
Remote by default, based in Los Angeles. On-site work can be arranged when the engagement needs it.
Per engagement, based on the written scope. Assessments and projects are usually fixed-fee; advisory is a monthly arrangement.