I'm going to be upfront about something. Regfo is not a replacement for an experienced regulatory professional. We don't negotiate with FDA. We don't write protocols. We don't sit in pre-IND meetings.
But I keep hearing the same thing from small biotech teams:
"We paid a consultant $15,000 to review our preclinical package. Half of what they found were basic gaps we could have caught ourselves if we'd known where to look." — RA Director, Series B oncology biotech
That's the part we handle. The mechanical, repetitive work of cross-referencing studies against ICH/FDA requirements. That shouldn't cost $500 an hour.
What a consultant engagement actually costs
I priced this out across six firms. Rates vary, but the pattern is consistent.
| Engagement | Typical cost | How long it takes |
|---|---|---|
| Preclinical package review | $10,000 – $50,000 | 2-4 weeks |
| Protocol compliance check | $5,000 – $15,000 | 1-2 weeks |
| Gap analysis with recommendations | $8,000 – $25,000 | 2-3 weeks |
| Monthly advisory retainer | $5,000 – $15,000/mo | Ongoing |
| Pre-IND meeting prep | $15,000 – $40,000 | 3-6 weeks |
For a full IND preparation, you're looking at $40,000 to $150,000. Senior consultants bill $300-500/hr. Junior staff bill $150-250/hr. Most firms have $10K engagement minimums.
(Sources: publicly listed rates from ProPharma Group, The FDA Group, and comparable firms.)
What Regfo costs
$399/mo for Pro. $999/mo for Team. That includes compliance checking, gap detection, scoring, shareable reports, ongoing monitoring as you add studies. No engagement minimum, no waiting three weeks for a deliverable.
I won't pretend these are the same thing. They're not.
The part we handle
Someone on your team is sitting with ICH M3(R2), S7A, S2, and a stack of PDFs open in browser tabs, manually checking whether your tox studies cover every requirement. We built a rules engine with 1,054 rules across 24 guidelines that does this in under 5 minutes. With specific citations for every finding.
You don't need to wait for a $15,000 engagement to find out you're missing a non-rodent tox study. Upload your reports now. See the gap now. Order the study now.
Every time you add a study to your workspace, the compliance score updates. You always know where you stand. A consultant gives you a snapshot from three weeks ago. And when you need everyone aligned, send your CSO a link to the compliance report. Send it to your investors. Send it to your CRO. No more "what did the consultant say?" emails bouncing around Slack.
The part that needs a person
Strategy calls that require judgment. "Should we pursue accelerated approval for this indication?" "How do we position our safety data in the pre-IND briefing document?" These aren't checklist questions. They require someone who's been in FDA meetings and knows how reviewers think.
Talking to FDA is the obvious one. Pre-IND meetings, Type B meetings, responding to clinical holds. You want a person who's sat across the table from CDER reviewers. Preferably someone who used to be one.
If your mechanism has no precedent, the guidelines are ambiguous by definition. You need someone who can interpret ambiguity and make a regulatory argument. Our rules engine covers published requirements. If there's no guideline, we can't check against it.
Sequencing decisions matter too: what to study first, what to defer, how to build your package so each piece supports the next. That's experience, not a database lookup. And some teams need help actually writing the IND sections. We check safety pharmacology compliance and your nonclinical overview, we don't write documents.
How smart teams use both
The best approach I've seen, from talking to about a dozen RA leads:
Run Regfo continuously from the start of your preclinical program. Catch the obvious stuff early. Keep your score updated. When you bring in a consultant for pre-IND meeting prep, they're not spending billable hours checking whether you have an Ames test. They already know you do because they looked at your Regfo report.
You just turned $15,000 of basic gap analysis into $15,000 of strategic advice.
One of the people I talked to put it well:
"I wish I had something that caught the obvious stuff so I could use my consultant hours for the hard questions." — VP Regulatory Affairs, Series A biotech (pre-IND stage)
Quick note on Veeva and the enterprise tools
People sometimes ask how we compare to Veeva or MasterControl. Short answer: we don't. They're document management systems. They organize your files. They don't read them.
| Tool | What it does | Cost | Built for |
|---|---|---|---|
| Veeva Vault | Document management, workflows | $100K-300K/year | Large pharma, 500+ people |
| MasterControl | QMS, document control | $50K+/year | Mid-size pharma |
| Kivo | Lightweight doc management | ~$10K/year | Emerging biotech |
| Regfo | Reads your studies, checks compliance | $399-999/mo | Series A-C biotech, 10-50 people |
Veeva manages documents. We read documents and tell you if they meet FDA requirements. Different tools, different problems.
(Source: G2 competitive analysis, Kivo alternatives overview)
What a typical workflow looks like
Here's what one Series B team did. They had 11 preclinical studies completed, IND filing planned for Q3. They'd been budgeting $45,000 for a consultant engagement to do the full gap analysis and pre-IND prep.
Instead, they uploaded their 11 study reports to Regfo on a Monday. By Tuesday morning they had a compliance score of 62/100 and a list of 7 specific gaps — missing recovery groups in the 28-day rat tox study, incomplete genotoxicity battery (two tests instead of three per ICH S2(R1)), and a safety pharmacology study that hadn't assessed respiratory function.
Three of those seven gaps would have cost them a clinical hold. The other four were documentation issues they fixed in a week.
They still hired a consultant. But the consultant spent zero time on basic gap identification. All of that $45,000 went toward pre-IND meeting strategy, FDA briefing document review, and helping them navigate an unusual toxicity finding in the non-rodent species. The stuff that actually requires 20 years of FDA experience.
Total cost: $45,000 (consultant) + $399 (Regfo for the month) = $45,399. For that, they got comprehensive gap analysis in 24 hours plus strategic regulatory consulting. Without Regfo, that same scope would have been $60,000-80,000 because the consultant would have spent the first two weeks doing what Regfo did in 5 minutes.
The math for a 15-person biotech
Running through the numbers for a typical Series A-B company with one active IND program:
| Scenario | Annual cost | What you get |
|---|---|---|
| Consultant only | $60,000 - $150,000 | 2-3 engagements/year, snapshot reviews, strategic advice |
| Regfo only | $4,788 - $11,988 | Continuous monitoring, instant gap analysis, no strategic advice |
| Both | $35,000 - $80,000 + $4,788 | Strategic advice focused on hard questions, continuous compliance monitoring |
The "both" scenario usually costs less than "consultant only" because you're not paying $400/hr for someone to read ICH M3(R2) Table 1 and check whether your repeat-dose tox study duration matches your planned clinical exposure. You're paying them for the judgment calls.
When we're not the right fit
I'd rather lose a sale than waste your time. Regfo probably isn't for you if:
- You have a 20-person RA department. You have the expertise in-house.
- You're working on something with zero regulatory precedent. We check against published guidelines. If the guideline doesn't exist yet, we can't help.
- You need someone to write your IND sections. We check, we don't write.
What happens when you switch consultants
This is a pain point nobody talks about. Your consultant leaves the firm. Or your company grows and the firm assigns a junior associate. Or you switch firms because pricing went up. Every time, you lose context. The new person needs to re-read everything, re-learn your program, re-form opinions about your regulatory strategy. That's weeks of billable onboarding where you're paying someone to read your own documents.
With Regfo, your compliance history lives in the workspace. Every study report, every score, every gap — it's all there. When a new consultant comes in, you hand them a link. They see exactly where you stand in 30 seconds instead of spending two weeks getting up to speed on a package they've never seen before.
I talked to one VP of Regulatory who said she'd switched consultants twice in 18 months and estimated she lost $30,000 each time in "re-learning costs." That's $60,000 spent on people reading documents they could have reviewed in Regfo in an afternoon.
Try it on one study
Upload a preclinical study report. Takes about 2 minutes. See what the compliance check finds. Then decide whether the gaps it catches are worth $15,000 of consultant time or $399 of Regfo.
Also see: FDA IND Submission Checklist 2026 for the full breakdown of what goes into an IND package.
Related: ICH Q1 Revision: Stability Testing
Consultant pricing based on publicly available rate information from ProPharma Group, The FDA Group, BioBoston Consulting, EMMA International, and industry surveys (2024-2026). Regfo pricing as of March 2026.