What it is
Most AI consultants don't understand regulated environments. They build general-purpose
workflows without accounting for audit trails, electronic signatures, validation requirements,
data integrity standards, or the documentation burden that comes with FDA oversight.
We design and implement Claude-based AI workflows specifically for pharma, biotech, and CDMO
environments — with traceability, human review checkpoints, and documentation practices
built in from the start. We work independently of Veeva, which means our scope and
recommendations aren't constrained by platform limitations.
Who it's for
- Pharma and biotech companies ($50M–$500M) running real R&D and compliance workflows
- CDMOs looking to automate documentation, batch record review, or deviation management
- Organizations subject to FDA 21 CFR Part 11 or EU Annex 11 requirements
- Quality and regulatory teams looking to reduce manual documentation burden
- Companies whose GxP environments have made AI adoption feel out of reach
Common use cases we implement
- Batch record review automation — AI-assisted review with human sign-off and full audit trail
- Deviation and CAPA documentation — structured AI drafting of deviation reports with regulatory language alignment
- SOP and technical writing assistance — Claude-powered drafting with subject matter expert review workflow
- Regulatory submission support — document organization, gap analysis, and structured summaries for submission packages
- Training documentation and knowledge management — searchable access to SOPs and technical documents with compliance metadata
What's included
- Regulatory and compliance requirements scoping (21 CFR Part 11, GxP, EU Annex 11 as applicable)
- Workflow design with human-in-the-loop checkpoints and audit trail requirements
- Claude implementation with validation-ready documentation
- Integration with existing QMS, document management, or ELN systems
- User Acceptance Testing (UAT) protocol and execution
- IQ/OQ/PQ documentation support (where required)
- Regulatory rationale documentation for AI use in GxP processes
Timeline
Typically 8–16 weeks, depending on the complexity of the regulated process, the number
of integrations, and the validation documentation requirements. Simple, single-process
implementations in less-regulated environments can be faster; full GxP environments
with validation requirements take longer.