# Regulatory & HTA evidence readiness
> Know what your evidence will withstand before the agencies test it.
Source: https://www.visfo.health/projects/regulatory-hta-evidence-readiness
Tags: Sprint

_Know what your evidence will withstand before the agencies test it._

A readiness assessment of the evidence base against regulatory and HTA expectations across priority markets, with the gaps, risks and remediation options set out before submission timelines close them off.

## What it is

An assessment of how the current evidence base is likely to hold up against regulatory and HTA expectations in the markets that matter, covering the clinical package, the comparative evidence, the economic case and the data underpinning each.

Built for teams approaching submission windows who need an independent read on where the evidence is strong, where it is thin and what can still be done about it. Expectations shift, so the assessment is explicit about where it is judgement rather than settled requirement.

## How we run it

1. **Frame** — Agree the markets, the agencies, the indication and the submission windows the assessment has to inform.

2. **Ingest** — Pull the evidence package, prior agency precedent for comparable assets, guidance and comparator positioning into one structured base.

3. **Synthesise** — Assess readiness dimension by dimension, score the risks, and set out remediation options with the time and feasibility each would need.

4. **Deliver** — Ship the readiness assessment, the risk register and a working session with regulatory, HEOR and access.

## What you get

- Readiness assessment by market and agency

- Risk register across clinical, comparative and economic evidence

- Precedent from comparable assets and prior agency critique

- Remediation options with feasibility and timing

- Working session with regulatory, HEOR and access