Singular platform for multi-department document Ops.

Singular platform for multi-department document Ops.

Our platform combines regulatory and medical writing expertise with AI-driven automation to deliver faster, error-free, and audit-ready documents — so your teams can focus on science, not paperwork.

R&D / Clinical

CSR

CSR

CSR

Protocols

Protocols

Protocols

Investigator Brochures

Investigator Brochures

Investigator Brochures

Manufacturing & Quality

CMC Sections (Module 3)

CMC Sections (Module 3)

CMC Sections (Module 3)

Regulatory Affairs

eCTD Modules (2–5)

eCTD Modules (2–5)

eCTD Modules (2–5)

NDAs/MAAs

NDAs/MAAs

NDAs/MAAs

Medical Affairs

Posters

Posters

Posters

Infographics

Infographics

Infographics

Medical Information Letters

Medical Information Letters

Medical Information Letters

Features built for your unique document workflows.

Features built for your unique document workflows.

AI-Powered Draft Generation

Auto-draft key regulatory and internal reports with built-in compliance for ICH, FDA, and EMA templates.

AI-Powered Draft Generation

Auto-draft key regulatory and internal reports with built-in compliance for ICH, FDA, and EMA templates.

AI-Powered Draft Generation

Auto-draft key regulatory and internal reports with built-in compliance for ICH, FDA, and EMA templates.

Regulatory Compliance Engine

Ensure every document aligns with global and local submission requirements.

Regulatory Compliance Engine

Ensure every document aligns with global and local submission requirements.

Regulatory Compliance Engine

Ensure every document aligns with global and local submission requirements.

Human in the Loop

The platform has numerous control points where the human is influencing the platform to drive the required output. 

Human in the Loop

The platform has numerous control points where the human is influencing the platform to drive the required output. 

Human in the Loop

The platform has numerous control points where the human is influencing the platform to drive the required output. 

Unified Knowledge Base

Centralized access to all protocols, SOPs, and validation documents — powered by semantic AI search.

Faster Time-to-Market

Centralized access to all protocols, SOPs, and validation documents — powered by semantic AI search.

Faster Time-to-Market

Centralized access to all protocols, SOPs, and validation documents — powered by semantic AI search.

Seamless Integration

Plug-and-play with your existing DMS, LIMS, ELN, QMS, and Veeva environments.

Seamless Integration

Plug-and-play with your existing DMS, LIMS, ELN, QMS, and Veeva environments.

Seamless Integration

Plug-and-play with your existing DMS, LIMS, ELN, QMS, and Veeva environments.

Smart QC Review

Review every data point in the report, and tag the source file for the provenance of the data.

Smart QC Review

Review every data point in the report, and tag the source file for the provenance of the data.

Smart QC Review

Review every data point in the report, and tag the source file for the provenance of the data.

AI-native platform to supercharge your outcomes.

AI-native platform to supercharge your outcomes.

Speed

Reduce document turnaround times from months to days 

Accuracy

Accuracy

High First Draft Accuracy

Compliance

Audit-ready format, reviewed by human decision-makers

Contact us

Contact us

Are you ready to take your document operations to the next level? Let’s talk about how Replicant can help you automate your workflows.

Ready to get started? Contact us today at sales@replicantsys.com to discuss your development needs. We look forward to working with you!

Ready to get started? Contact us today at sales@replicantsys.com to discuss your development needs. We look forward to working with you!

Ready to get started? Contact us today at info@replicantsys.com to discuss your development needs. We look forward to working with you!

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