Engineering and regulatory support, designed together.

Bio-Consultant brings AI and software development into the same conversation as regulatory strategy—so the product, the evidence, and the path forward can be considered together.

Discuss an engagementExplore capabilities

Two connected capabilities

Engage either discipline independently, or bring them together around one program.

AI/ML-focused software development

Support for biotech software and data workflows—from an early technical question to a maintainable implementation.

  • Problem and data framingClarify the decision, available data, constraints, and useful measures of performance.
  • Model and prototype developmentExplore analytical approaches and turn promising directions into testable software.
  • Scientific data workflowsDesign reproducible pipelines for research, analysis, and operational use.
  • Engineering and deployment planningConsider architecture, testing, traceability, monitoring, and cloud delivery from the outset.

Work can involve Python, R, TensorFlow, PyTorch, AWS, and GCP where they fit the project—not as a prescribed stack.

Regulatory affairs

Practical regulatory support that connects requirements with the work product, documentation, and decisions behind it.

  • Regulatory landscape and strategyFrame applicable pathways, open questions, dependencies, and near-term priorities.
  • Requirements and gap assessmentReview current processes and artifacts against the needs of the program.
  • Evidence and documentation planningOrganize the rationale, records, and review points needed to support clear decisions.
  • Standards-aware implementationSupport planning related to FDA 21 CFR Part 11, EU IVDR, and ISO 13485, as applicable.

The scope is tailored to the product, intended use, development stage, and applicable jurisdiction.