Built for the space between science, software, and regulation.

Bio-Consultant supports biotech teams working through complex technical and regulatory questions. The focus is narrow by design: AI/ML-centered software development and regulatory affairs.

See the scope of services

The practice

Biotech development rarely separates neatly into a technical track and a regulatory track. Product intent shapes software decisions; software decisions shape the evidence and documentation a team will need.

Bio-Consultant exists to help teams reason across that boundary. An engagement can focus on one defined need or connect both disciplines around a shared program.

Technical focus
AI/ML, scientific software, data workflows, and implementation planning.
Regulatory focus
Strategy, requirements, gap assessment, evidence, and documentation planning.
Working context
Biotech programs where scientific, engineering, and regulatory decisions interact.

How the work is approached

The aim is not to add ceremony. It is to make the important decisions visible, examine the assumptions behind them, and turn them into useful next steps.

  1. 01

    Start with the real question

    Define the decision to be made before selecting a method, tool, or deliverable.

  2. 02

    Work from the full context

    Consider scientific intent, data, users, risk, regulation, and operating constraints together.

  3. 03

    Make the reasoning usable

    Communicate the rationale, tradeoffs, open questions, and next actions clearly enough to carry forward.

Bring the complicated part.

Share the decision, roadblock, or workstream you are facing. A first conversation can help determine whether there is a useful fit.

Start a conversation