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MLR Review

Medical Legal Regulatory review and approval workflow with real-time collaboration, AI-assisted references, and FDA-compliant electronic signatures.

Solution by Papercurve
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Overview

Papercurve for Medical Legal Regulatory (MLR) Review is a content review and approval platform designed for life sciences and pharmaceutical teams that need to manage MLR workflows with audit-ready compliance. It targets medical, legal, and regulatory reviewers who collaborate on promotional and clinical content, supporting faster review cycles and consistent claim management.

The platform aims to reduce content review and approval times by up to 60% through real-time collaboration, AI-assisted referencing, and consolidated feedback tools. It also supports external reviewers such as regulators and key opinion leaders without requiring them to hold a platform login.

Collaboration Features

  • Reviewers can leave comments directly on content in a centralised, easy-to-find location.
  • Team members can be mentioned within comments to prompt faster responses.
  • Search, sort, and filter options allow comments to be located quickly and prevent feedback from being overlooked.

Approval Workflow

  • Real-time visibility into who has approved content and who is still reviewing.
  • Reviewers can approve, approve with comments, or request a new version if modifications are needed.
  • Approvals are stored with an FDA-compliant electronic signature to support audit requirements.

Reference and Evidence Management

  • Reviewers can link to external documents to support medical claims and provide context during the approval process.
  • Paige AI assists with linking references, claims, and translations by recommending relevant sources based on previous usage, improving both speed and accuracy.

Promotional Product Claim Management

  • Approved phrases are stored in a central location where they can be traced and reused across the platform.
  • Centralised claim storage supports onboarding of new team members by ensuring only approved claims are accessible and used.
  • Helps maintain content consistency across promotional materials.

External Reviewer Access

  • Content can be shared with individuals outside the workspace, such as regulators or key opinion leaders, without requiring a platform login.
  • External reviewers can leave comments, provide approvals, and add signatures directly.

Papercurve is based in Toronto, Canada, and offers integrations, data security documentation, and a knowledge base for platform support. The tool is positioned as an alternative to solutions such as Veeva Vault for MLR review workflows.

Meta

Domain
Commercial & Medical Affairs
Subdomain
Medical Affairs Operations
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechMedical Devices
Development stage(s)
ClinicalPost-Market & RWE
Target user(s)
QA / Regulatory AffairsMedical Affairs ProfessionalCommercial / Market Access
Compliance standard(s)
21 CFR Part 11
Tag(s)
Uses AI