FDA submissions
in a flash.
Volta’s senior regulatory affairs experts prepare submission packages with the help of cutting-edge tools to bring your innovations to market faster.
One expertly strategized package.
One short timeline.
One fixed price.
Built at the intersection of world-class engineering and regulatory expertise.
Yesterday’s submission process can’t keep up
Other regulatory teams take weeks to deliver. Hourly pricing means you don’t know what you’ll pay until the bill comes.
One package, one timeline, one price.
Volta empowers leading regulatory experts with custom-tailored AI tools to deliver faster, more thorough submissions.
Data room management
Gigabytes of messy zip files cleaned, structured, and organized in minutes by a team of AI agents.
No room for hallucinations
Highly structured AI agents create the first draft of your submission, with each claim fully traceable and linked back to the evidence that supports it.
Iterative senior review
Our senior regulatory experts set the strategy, then challenge the accuracy, logic, and evidentiary support, verifying every claim.
A maximum price, agreed first
Deliverables, delivery date and the most you can be charged, fixed before drafting starts. No retainer, no hourly billing.
How it works
Five steps. You know the price after step one.
Appraise
We confirm program fit, strategy, and feasibility, then scope the engagement. You leave this step with a price and a date, or an honest no.
More time advancing your program. Less carrying the paperwork.
What the agents do
- Indexes every document you send into one traceable source set
- Holds the link between each drafted claim and its underlying page
- Flags version mismatches, duplicate methods and unsupported statements
- Ensure information stays up-to-date as plans change
What the experts do
- Interpret the science and set the strategy
- Apply expertise to predict what the agency will actually ask
- Shape your communication with regulators
- Verify accuracy and address any gaps before delivery
Frequently asked questions
A full, integrated submission package, delivered on the agreed date.
A senior regulatory expert, not software. They set the strategy, shape the questions posed to regulators, challenge drafts on accuracy, regulatory logic, and evidentiary support, and address any gaps. Expert availability is confirmed during the appraisal.
Because the appraisal comes first. We look at your material, confirm the program fits a bounded package-authoring engagement, and only then commit to deliverables, a delivery date and a maximum price. If the material does not support that, we say so instead of quoting.
Your existing CMC, nonclinical and clinical-planning materials, program history, and any prior correspondence with regulators. We work from what you already have.
Your materials are used to build your package and nothing else. Specific handling, retention and access terms are set out in the engagement agreement before any material changes hands, so you can review them against your own requirements.
Then the appraisal ends there and you owe us nothing. We would rather decline or rescope than take on an engagement we cannot deliver against a fixed date and price.
Start with the appraisal.
One call to confirm scope, prerequisites and program fit. You leave it knowing the deliverables, the delivery date and the most it can cost, or knowing that we are not the right call right now.
A good fit
- StageAdvancing an IND- or IDE-enabling program
- EvidenceCMC, nonclinical, and clinical materials to work from
- HistoryPreparing for a first regulatory interaction or building on prior correspondence
We may recommend a narrower scope or a later start when critical inputs are missing, the development strategy is still changing, or the work requires regulatory rescue beyond the agreed package.