Oraxis Tech

Life Sciences / Dossia

Cut dossier drafting time
up to 70%.

Dossia is the AI-native drafting platform built for biopharma regulatory teams. It turns your source evidence into structured dossier drafts across CTD modules—Administrative, Summaries, Quality, Nonclinical, and Clinical—while your experts review and approve every claim.

Life sciencesNew industry focus · Paid pilot approach

Introducing Dossia

AI for regulatory
submissions.

Every draft carries full traceability back to your source evidence, so your regulatory experts can verify, edit, and approve before anything moves forward.

Explore a paid pilot Dossier coverage
Flexible deploymentOraxis Tech-managed SaaS or your approved environment
Connected to source evidenceTraceability for expert review
Your team approvesHuman judgment stays central
Explore the five modules and pilot scope
  1. 01Administrative & labeling
  2. 02Summaries & overviews
  3. 03Quality / CMC
  4. 04Nonclinical reports
  5. 05Clinical reports

Dossia's intended scope spans all five dossier modules. A paid pilot evaluates agreed content using your source material, infrastructure, and review criteria. Coverage, integration requirements, and results are validated per customer. Final scientific and regulatory approval remains with your team.

A focused first step

Start with one
real submission.

A paid pilot evaluates agreed content using your source material, infrastructure, and review criteria. Establish the fit before a wider commitment.

01

Define the pilot

Select the source evidence, dossier sections, deployment approach, review responsibilities, and success criteria.

02

Configure and generate

Connect the approved evidence and prepare the AI-assisted draft with references and traceability for review.

03

Expert evaluation

Your regulatory specialists assess quality, references, review effort, and readiness for broader adoption.

Up to 70% less manual drafting time

Based on Dossia's internal benchmarking on comparable dossier sections. Actual results for your content are measured and confirmed during your paid pilot.

Useful answers

Before we begin.

Who stays accountable?

Your scientific and regulatory experts review and approve the content. Dossia assists with drafting and evidence assembly.

Where does it run?

Dossia can be offered as an Oraxis Tech-managed SaaS solution or configured within your organization’s approved cloud and model environment. Security, data access, integrations, and operating responsibilities are agreed during scoping.

What results can we expect?

Results depend on the source material and agreed content. Quality, traceability, and drafting or review effort are assessed in the pilot rather than guaranteed in advance.

Let the science move forward

Your business
comes first.

Discuss your submission needs and what a focused Dossia pilot could look like.

Start a conversation