AI Consulting in San Diego

ITAR compliance starts with data routing. Before we scope any automation for a defense contractor, the audit maps every data element the workflow will touch and classifies it against the USML categories relevant to that contract. Export-controlled technical data — CAD files, specifications, test parameters — never routes through a shared multi-tenant SaaS endpoint without a ITAR-compliant data handling agreement. For most BD and contract workflows, the controlled data is narrower than operators expect: proposal text referencing unclassified program names is different from the underlying technical specs. We separate those flows architecturally, route the controlled elements through on-prem or FedRAMP-authorized infrastructure, and keep the uncontrolled workflow automation on standard tooling. The audit deliverable includes a written data-flow diagram the contractor's compliance officer can review before go-live. We don't promise ITAR certification — that's a legal determination — but we build to a standard a compliance officer can defend.

FDA-adjacent automation is buildable, but the architecture requirements are specific. For biotech regulatory affairs teams working under 21 CFR Part 11 or preparing submissions for IND, NDA, or BLA packages, the audit trail is the non-negotiable. Every automated step that touches a submission artifact needs a timestamped, attributable log: who triggered it, what input it received, what output it produced, and whether a human reviewer approved the output before it moved downstream. We build with audit trail integrity as a first-class requirement, not a bolt-on. That means structured logging to a write-once store, role-based access controls scoped to the document type, and version lineage that traces back to the source data. On the model side, we use no-training, zero-retention API endpoints so submission content never enters a shared training pipeline. The result is a workflow a regulatory affairs director can walk an FDA inspector through without reconstructing from memory.

Semiconductor IP is among the most tightly controlled data in commercial tech. For engineering and operations teams working on chip design, EDA toolchains, or supplier qualification in the Qualcomm orbit, the risk isn't just competitive — trade secret exposure in this sector carries legal consequence. Our starting position on any semiconductor engagement is air-gap the IP. Automation that touches design files, mask data, or process parameters runs in an isolated environment with no outbound API calls to general-purpose LLM endpoints. For workflows that don't touch controlled IP — supplier onboarding, meeting notes, administrative scheduling — standard tooling is fine. The audit separates those two categories clearly before any build starts. We also review the client's existing data classification policy and make sure the automation stack maps to those tiers, so the engineering team isn't making ad-hoc decisions about what's safe to route through which system.

HIPAA compliance in a research and clinical setting has more surface area than most operators expect. Research coordinators pulling patient cohort data, clinical ops teams routing referral workflows, and health system administrators managing credentialing all touch PHI in different ways, and the automation architecture has to match each use case. We sign a Business Associate Agreement before any PHI-adjacent build starts — that's table stakes, not a differentiator. What matters after that is scoped access: the automation pulls only the minimum necessary data fields the workflow requires, never full record access. API credentials are role-scoped and rotated on a defined schedule. On the model side, PHI routes through zero-retention enterprise endpoints with a signed DPA, not shared inference infrastructure. For academic medical settings with a mix of research and clinical workflows, we map both separately in the audit because the regulatory posture differs — the clinical side lives under HIPAA's minimum necessary standard, the research side may sit under IRB data use agreements with their own handling requirements.

Defense contractors most often start with proposal and BD workflow automation — tracking opportunity pipelines across SAM.gov and GovWin, auto-populating past performance write-ups from prior submissions, routing RFP sections to the right subject matter experts with deadline reminders. It's high-repetition, time-sensitive work that's currently eating BD coordinator hours. The ITAR considerations are manageable because most BD content is unclassified. For biotech operators, regulatory document assembly is the most common first build — pulling study data from instrument systems, assembling structured sections of a submission package, and flagging version mismatches before a submission goes to QA review. In both cases, the $99 audit surfaces which workflow is leaking the most time before we scope a build. We don't guess at the highest-leverage target; the audit produces a written prioritization with time estimates, compliance notes, and a recommended build sequence the operator can take to their leadership team.