Pharma R&D background
Our team built AI and ML systems inside large pharma. We know what ELN data looks like, how regulatory submissions get assembled, and what a LIMS integration actually requires.
PHARMA & BIOTECH
AI built by people who came from pharma
Early-stage biotech ops teams are running clinical programs, regulatory submissions, and commercial launches with a fraction of the headcount big pharma has. We close that gap with AI automation, fit-for-purpose internal tools, and content pipelines built by engineers who came out of pharma R&D.
We know what your ops team actually deals with
Not a generic AI agency that learned pharma from a Wikipedia page.
No discovery tax
Generic agencies spend your first two months learning your domain. We don't need a primer on CDISC, GxP, 21 CFR Part 11, or eCTD formatting. We start building in week one.
Built for your stage
Veeva and Oracle Clinical are overkill for a 30-person Series A. We build fit-for-purpose tools that give you big-pharma infrastructure at startup cost and startup speed.
The operational reality at Series A/B
You're running clinical programs, regulatory submissions, and pre-commercial work with a team that would be one department at a big pharma.
Data wrangling that shouldn't be manual
Assay results parsed by hand. ELN exports reformatted in Excel before anyone can read them. LIMS outputs that require three steps before they're usable. Your scientists are doing data janitorial work instead of science.
Regulatory docs assembled from scratch every time
IND sections, nonclinical summaries, clinical overviews — each one is a document assembly exercise across 15 data sources. No templates, no automation, no institutional memory beyond the people who did it last time.
Clinical ops tracked in spreadsheets
Site activation status in one sheet. Enrollment in another. Vendor milestones in a third. A SharePoint folder that no one can navigate. You're running a Phase 2 trial on infrastructure built for a 10-person startup.
Content volume that outpaces headcount
Pre-commercial planning, KOL briefings, payer dossiers, MSL decks, patient education materials, HCP content — all of it needs to exist before launch. A 60-person company cannot produce this volume with headcount alone.
What we build for pharma and biotech
Three service areas. All of them specific to your ops reality.
Automation
Lab & regulatory pipelines
Automate the path from raw experimental data to structured, submission-ready outputs. Connect your ELN, LIMS, and EDC systems so data moves without manual intervention.
- ELN/LIMS data extraction and normalization
- Assay result parsing and structured reporting
- Regulatory document assembly (IND, NDA, eCTD inputs)
- Cross-reference validation and consistency checks
- Automated summary generation for internal review
Internal Tools
Clinical & ops dashboards
Replace the spreadsheet stack with purpose-built internal tools that give your ops team real visibility — built in weeks, not quarters.
- Clinical trial enrollment and milestone dashboards
- Regulatory submission trackers (IND, NDA, MAA)
- Site activation and vendor coordination portals
- Compound and assay tracking tools
- Biomarker and translational data viewers
Content Pipelines
Scientific & commercial content
AI-assisted content pipelines grounded in primary literature — for pre-commercial teams that need volume without sacrificing scientific accuracy or regulatory compliance.
- KOL briefing decks and MSL slide content
- PubMed-grounded blog and whitepaper pipelines
- Payer dossier and reimbursement support content
- HCP educational and disease awareness materials
- Thought leadership for investor and analyst audiences
Who we work with
We're the right fit for a specific stage and a specific kind of buyer.
Early-stage biotech (Series A/B, 10–100 employees)
You've closed your funding, you're in clinical development or approaching IND, and your ops infrastructure hasn't caught up to your science. You need tools that work now, not in 18 months after an enterprise implementation.
Small and mid-size CROs
You're differentiating on speed and quality, not headcount. AI-assisted document generation, protocol tooling, and site management dashboards let you deliver more without proportional hiring.
Pre-commercial pharma (approaching first launch)
Your PDUFA date is in sight. You're building the field team, the payer strategy, and the medical affairs content simultaneously. The content volume problem is real and the timeline doesn't move. We help you scale output without scaling headcount.
Regulatory affairs and clinical ops teams
You're the buyer if you're assembling INDs in Word documents, tracking submission deadlines in a shared spreadsheet, or spending two days before a milestone meeting pulling data from five different systems into a single slide deck.
How engagements work
Predictable delivery. No open-ended retainers before you've seen results.
1. Discovery call (free)
We identify the highest-leverage automation or tooling opportunity in your current ops. You leave with a specific recommendation whether or not you engage us.
2. Fixed-scope build
We scope a specific deliverable — a pipeline, a dashboard, a content system — with a defined output and a defined timeline. No discovery phases that stretch to six months.
3. Ongoing retainer (optional)
Maintain, extend, and evolve the system as your programs progress. Priced for biotech budgets, not big-pharma vendor contracts.
Four months from PDUFA? Mid-trial data crunch? Just closed your Series A?
Tell us what's on fire in your ops. We'll tell you what AI can actually fix and how fast.