AI that ships.
Experts in the loop.
Amia Agency designs, builds and runs AI for pharma, biotech and regulated enterprises. Agents, regulatory workflows and automation, delivered as finished work and reviewed by people who are accountable for it.
- Source-traced
- Expert-reviewed
- On your cloud
- 21 CFR Part 11-aware
Four practice areas,
one delivery model.
Every engagement is scoped in writing and delivered as finished work, with strategy included.
Agentic AI & LLM Apps
Custom agents, copilots and LLM tools that plan, retrieve and act across your systems, with guardrails and human checkpoints.
Learn more →Regulatory & Pharma AI
IND gap assessments, drafting support, clinical summaries and validation documents, source-traced and expert-reviewed.
Learn more →Enterprise Automation
Governance-first automation for document-heavy, compliance-sensitive work, run on your infrastructure by our team.
Learn more →AI Strategy & Readiness
Use-case discovery, pilot design, evaluation plans and governance, written down and ready to execute.
Learn more →Built, tested and demonstrable.
Case studies from our regulatory and healthcare AI work. Client names are anonymized.
MedNova IND Gap Assessment
A source-traced IND gap assessment platform that finds missing and inconsistent content before the FDA does, with an expert reviewing every finding.
Live demonstration (demo data)Read case study →AI-enabled validation documentation for a global bioprocessing leader
Report generation for validation documentation, measured against the client's own golden output, with a reproducible and traceable approach.
DeliveredRead case study →From pre-IND to full IND: extending MedNova
Extending a pre-IND analysis tool into a full-IND gap analysis and generation workflow, with regulatory content supplied and reviewed by domain experts.
In developmentRead case study →Assess. Pilot. Build. Run.
A four-step model that gets AI into production on your infrastructure, with accountable experts reviewing the work before it reaches you.
Assess
We agree the scope, the question you need answered and the review cycles included, in writing.
Pilot
A focused pilot proves the workflow on your data before any broader build or commitment.
Build and deploy
We build the production system on your infrastructure, with evaluation and monitoring baked in.
Run and support
We operate, monitor and improve it: model updates, performance tracking and expert review on call.
Proven where the stakes are highest.
The tool demonstrated strong accuracy against the client's golden output, including placeholder filling and table population, and showed a reproducible, traceable approach to report generation.
$6B global leader in bioprocessing technologies and biopharmaceutical manufacturing solutions
Amia.ai demonstrated exceptional responsiveness to evolving requirements, rapidly adapted to our specific technical documentation needs, and maintained a collaborative, solutions-oriented team culture throughout the engagement. Their ability to execute and adapt made them a strong technology partner.
Large biopharma company, Massachusetts
Amia's MedNova IND gap analysis identified several critical gaps and missing elements that our regulatory writers had overlooked. Without these findings, we could have submitted an IND containing incomplete or inaccurate information, potentially leading to costly delays and additional FDA scrutiny.
San Diego-based clinical-stage biotechnology company
Company and executive identities are available to qualified investors under a signed NDA, subject to disclosure authorization. Testimonials 1 and 2 are from the same enterprise engagement.
What people ask first.
What kinds of projects do you take on?
Agentic AI and LLM apps, regulatory and pharma AI workflows, enterprise automation for document-heavy work, and AI strategy and readiness. We lead with pharma and life sciences and bring the same governed approach to other regulated industries.
Do experts review the work?
Yes. Software drafts, experts decide. In our regulatory work, an expert reviews every finding before it reaches you, and every statement is linked back to its source.
How is pricing set?
Every engagement is scoped in writing and priced after a scoping call. There are no seats or licenses; you pay for the deliverable, and strategy is included in the engagement.
Where does the system run, and who sees our data?
On your infrastructure: AWS, Azure or GCP, or on premise by arrangement. Access is role-based and activity is logged. We are happy to sign an NDA before you share anything.
Can we see examples of your work?
Yes. See the portfolio for case studies and demonstrations. Client names are anonymized, and additional project details and professional references may be provided upon request, subject to confidentiality and prior approval.
How quickly can we start?
Most engagements begin with a 30-minute scoping call and a written scope. If you have a deadline, say so in the project brief and we will tell you plainly what is realistic.
Know where you stand
before you build.
Tell us about your AI initiative or your next filing. We will tell you what a scoped engagement would cover and how it would be priced.