The only submission review
you pay for only if it
saves you.
UpRegulate has analyzed every publicly available FDA Complete Response Letter, guidance document, and enforcement action — across every regulatory body worldwide. Before your submission reaches a reviewer, we find what they find.
No engagement fee if we find no material deficiencies. · All submissions handled under strict NDA.
The Proposition
Zero downside.
Significant upside.
You engage UpRegulate before your submission reaches reviewers. If our analysis finds no material deficiencies, there is no success fee. You have completed the most comprehensive AI pre-submission review available and move forward with that assurance on record.
If we find something — a gap that mirrors what FDA has cited in prior refusals in your category — you have the rarest thing in this process: time to fix it before it reaches a reviewer's desk.
That is not consulting. That is leverage.
We find nothing
No success fee
Move forward with the most comprehensive AI pre-submission review on record. The engagement fee is your only cost.
We find something material
You fix it first
Avoid a Complete Response Letter. Avoid 6–18 months of delay. Avoid the market impact.
345+
Complete Response Letters analyzed
Every FDA CRL in the public record — every deficiency, every refusal, every pattern
52,856
FDA documents in corpus
Guidance documents, review summaries, inspection reports, PDUFA commitments
67,000+
Total regulatory documents
FDA, EMA, PMDA, and additional jurisdictions — continuously updated
10,295
Extracted deficiency rules
Structured and categorized across CMC, Clinical, Safety, Manufacturing, Labeling, and more
The Intelligence Advantage
No human team has read what UpRegulate has read.
FDA
52,856 documents
- —Every finalized guidance
- —Every Complete Response Letter
- —Inspection closeouts
- —Advisory committee transcripts
- —PDUFA meeting minutes
EMA
11,548+ documents pending
- —EPAR assessment reports
- —Scientific guidelines
- —Refusal-of-marketing-authorization letters
- —CHMP opinions
- —Biosimilar guidance
PMDA
Japan regulatory corpus
- —New Drug Application reviews
- —Partial change approvals
- —Safety updates
- —Clinical pharmacology guidance
- —Post-marketing requirements
A team of regulatory consultants, even a large one, reads hundreds of documents over years. UpRegulate has processed tens of thousands, systematically, in structured form — and every new guidance document, CRL, and enforcement action is added continuously.
What Stops Approvals
Five categories account for virtually every CRL ever issued.
The most common CRL trigger. FDA cited CMC deficiencies in over 40% of Complete Response Letters analyzed.
Representative deficiency patterns
- ›Container closure system not adequately qualified
- ›Validation data insufficient to support proposed shelf life
- ›Control strategy for drug substance not adequately characterized
- ›Comparability data inadequate following manufacturing site change
UpRegulate's analysis maps your submission against 10,295 structured deficiency rules extracted from the public CRL record. Any finding that matches a pattern FDA has cited in prior refusals in your category constitutes a Submission-Derailing Finding.
Structure
Aligned with your outcome.
Our fee structure is designed so we only earn a meaningful return when we deliver something that materially changes your outcome.
Standard Engagement
$25,000
Engagement retainer · billed on commencement
+ Success Fee
Triggered upon delivery of a Submission-Derailing Findings report — a report identifying any material deficiency that matches a pattern FDA has previously cited as grounds for refusal in your application category.
- —Full eCTD pre-submission screen
- —Structured findings report within 10 business days
- —Category-specific deficiency map against CRL database
- —Regulatory pathway risk assessment
- —Direct access to review findings
Founding Client
All-In Founding Rate
$175,000
All-inclusive · engagement retainer + success fee
Fixed price regardless of findings. Founding clients receive priority scheduling, dedicated review sessions, and direct access to the team behind the platform.
- —Everything in Standard
- —Priority scheduling — first available review window
- —Dedicated findings walk-through session
- —Input on intelligence roadmap priorities
- —Preferred terms for future engagements at our discretion
Founding client pricing includes a contractual commitment to provide a testimonial upon completion. This requirement is part of the discount structure.
Smaller Companies & Pre-Revenue Biotechs
For companies where approval represents a step-change in equity value, we are open to discussing structures that include warrants or equity participation alongside the cash component. Cash is always included. Reach out to discuss.
Confidentiality
Your submission material never leaves a secure environment.
Every engagement begins with a mutual NDA executed before any submission materials are shared. Our analysis is conducted in an isolated, encrypted environment. No submission data is retained beyond the engagement period. No findings are shared with any third party.
We understand that pre-approval submission content is among the most sensitive proprietary material a company holds. Our confidentiality obligations are absolute.
Who We Are
Built by strategists.
Powered by AI.
UpRegulate was built by Gregory Bibas — a Bain & Company alum and Wharton MBA who applied the same analytical rigor used in high-stakes M&A and corporate strategy to a domain where that rigor has historically been unavailable at scale: regulatory pre-submission review.
The insight was straightforward: FDA publishes every deficiency it has ever cited, in structured form, across hundreds of Complete Response Letters. That corpus is public. The patterns are consistent. No one had systematically extracted and operationalized them — until now.
We are a technology team, not a regulatory consultancy. We do not offer regulatory strategy, clinical design advice, or pre-IND consultation. We offer one thing: pattern-matched intelligence against the largest structured CRL database ever built.
Approach
Every rule in our database was extracted from an actual FDA enforcement moment — not an interpretation of guidance, but a verbatim deficiency cited in a letter that caused a company to restart its review clock. These are not hypotheticals. They are precedents.
Scope
UpRegulate began in pharmaceutical drug applications and is expanding to biologics, combination products, medical devices, and additional global regulatory jurisdictions. The underlying intelligence platform applies wherever agencies publish structured enforcement records.
Credentials
Gregory Bibas holds an MBA from The Wharton School, University of Pennsylvania, and worked at Bain & Company advising on strategy and operations across healthcare and technology clients.
Request a Review
Confidential. No obligation
until we agree on scope.
Tell us about your application. We will respond within one business day to discuss whether UpRegulate is appropriate for your submission, timing, and engagement structure.