Venitara Investor Proof
Diligence Ready
Regulatory due diligence for founders and investors
Your regulatory position, the risks in it, and what remains to be spent, written for an investor and drawn from the technical file you already hold.
Where this sits
Your file, growing. Each stage begins with the work already in it.
Available at any stage
Diligence Ready
Fully ReadyWhen to use Diligence Ready
A funding round, a term sheet, or a data room requires a documented view of where you stand, and the honest answer is spread across four people and a shared drive.
Regulatory opacity discounts valuations. An investor who cannot see the position prices the uncertainty, and the discount is usually larger than the work costs.
What you receive
The Regulatory Due Diligence Pack
The current status, the material risks, the next milestones, and the expected regulatory spend, in the language an investment committee reads.
What it contains
Current regulatory status, by market
Material risks, and what closes each one
The next milestones and their dependencies
Expected regulatory spend to certificate
What the pack draws on
| Source | What it provides |
|---|---|
| The classification rationale | What the product is, and the route that follows |
| The evidence map | What exists, and what is still to be generated |
| The quality system records | Whether the company can operate what it has built |
| Attestations already issued | Which documents a named expert has read, and when |
| The market sequence | Where revenue starts, and when |
Who does the work, and against what
The pack is assembled from evidence that already exists rather than written for the data room, which is why it survives being checked.
Venitara has worked in cooperation with ten to twelve Notified Bodies and delivered more than forty regulatory projects.
What you can do with the result
An investor can diligence your regulatory position in an afternoon, and what they find matches what you told them.
You can answer the spend question with a number that has a plan behind it, which is the question that follows every regulatory conversation in a funding round.
The two levels for this product
Explore | Attest | |
|---|---|---|
| What you get | The pack assembled from your own answers and existing records | The pack read by a named senior expert and attested |
| Human review | No expert review | Reviewed by a named senior regulatory expert |
| What it may claim | An indicative working view | That this pack was ready for submission on the date it was read |
| The mark | A notice that no regulatory expert has read it | The Attestation seal, on the document |
The Venitara Attestation records that a named senior regulatory expert has reviewed this document against the Venitara rubric, confirming concordance with the applicable regulatory requirements and assessing it as ready for submission at a defined point in time. It is not a conformity assessment under Regulation (EU) 2017/745, regulatory approval, a Notified Body certificate, or a guarantee of approval.
Scope and limits
Three things this product does not do
Improve the position it describes.
The pack reports what is there. Where the position is weak, the pack says so, and closing it is the other products.
Speak for you in diligence.
The pack is yours to present. Venitara can answer questions on the reviews it performed.
Value your company.
The regulatory position is one input to a valuation, and the pack does not offer a view on the rest.
Where this leads
Submission Ready.
If the pack shows the technical file is close, an expert reading is what turns close into dated and defensible.
Fully Ready.
A technical file that is current on any day an investor asks removes the need to assemble a pack each time one does.
Common questions
How long does it take?+
It depends on what already exists. Where a Venitara technical file is in place, most of the pack is assembly. Where it is not, the work starts with an inventory of what you hold.
Can we use this in a data room?+
That is what it is for. It is written to be read by people who are not regulatory specialists and checked by people who are.
What if the position is bad?+
The pack says so. A due diligence pack that only works when the news is good is worth nothing to the person reading it, and worse than nothing to you when they check.
Is this the same as the Attestation?+
No. The Attestation is a named expert's reading of one document. The pack is a summary of the whole regulatory position, and it cites any Attestations you hold.
Need an expert read before the technical file leaves your company?
If you are still working out where to begin, the free MedTech Compass takes about ten minutes.
Free · AI generated · 10 mins