Regulatory Writing

Made Easier with

GenAI

A cutting-edge, document-agnostic platform for creating any documents in your product cycle, from discovery through regulatory submissions, medical communication and beyond

Regulatory Writing Made Easier with

GenAI

A cutting-edge, document-agnostic platform for creating any documents in your product cycle, from discovery through regulatory submissions, medical communication and beyond

Regulatory Writing

Made Easier with

GenAI

A cutting-edge, document-agnostic platform for creating any documents in your product cycle, from discovery through regulatory submissions, medical communication and beyond

regain

regain

REGAIN (Regulatory Submissions Excellence using Generative AI Navigator) transforms document generation with AI-powered precision—accelerating the creation of every report a pharma company needs, from preclinical to post-marketing, in a fully compliant, intuitive platform designed to meet global regulatory standards.

Structured Content
Supercharged by GenAI

Value offered by REGAIN

Lightning-Fast Document Creation

REGAIN helps you

Reduce reporting time and increased productivity through AI automation

Differentiator

  • From tables to insights in seconds
  • Produce your first drafts in less than a day!

Exceptional Consistency, Low QC Overhead

RIA helps you

Higher regulatory confidence and compliance via SME-reviewed outputs

Differentiator

Ensure submissions meet the highest standards with SME-validated, compliant outputs.

Cross-Functional Collaboration Made Simple

RIA helps you

Higher regulatory confidence and compliance via SME-reviewed outputs

Differentiator

Ensure submissions meet the highest standards with SME-validated, compliant outputs.

How it Works

01

Ingest

Upload input documents such as IB, Protocol, SAP, TLFs, Publications etc.

02

Instruct

Prompt GenAI engine to automate text generation & even translation

03

Review/Edit

Receive your draft report in minutes saving valuable resources & time

REGAIN Innovative Features

REGAIN streamlines document workflows with custom templates, AI-generated content, real-time collaboration, and secure, role-based access controls.

Custom Template Generation and Management
Real-Time
Team Collaboration and Commenting
Generate relevant sections using AI

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Recommended Section

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Analyzing Document…

Recommended Section

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Admin Control &
Role Based Permission Control

Admin

Admin

Authoring Manager

Authoring Manager

Reviewer

Reviewer

Review made easy!
Requested a Revision
Requested a Revision
Revision is in progress!
Revision is in progress!
Integrate your Database Securely

Latest Document List

In Production

CSR (Clinical Study Report)

SRD (Scientific Response Document)

ICD (Inform Consent Document)

SAP (Statistical Analysis Plan)

PLS (Plain Language Summaries)

Abstracts

Work in Progress

CTD Summaries (M2/M5)

Investigator's Brochure

Protocols

PSURs/DSURs

Manuscripts

Narratives

DRG (Data Reviewer Guide)

Ready to Innovate?

Let’s start your journey toward innovation. Get in touch with us today to see how Vivpro can empower your team and drive your success.