AI-powered intelligent assistant in the MLR review process

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Why Elmer AI?

Unmatched Versatility

Elmer supports a wide range of products, including drugs (OTC, NDA, IND), medical devices, and cosmetics, adapting effortlessly to diverse regulatory needs.

Version Control & Tracking

Easily manage asset versions and track every change, ensuring comprehensive version history and streamlined oversight.

Continuous Optimization

Elmer improves iteratively through user feedback, constantly refining its performance for optimal outcomes.

Intelligent Product Grouping

Applies consistent rules across similar products or product lines, enhancing accuracy and efficiency.

Robust Security

Implements high-security protocols within your environment, providing rigorous data protection.

Seamless Workflow Integration

Integrates smoothly into existing workflows, including digital asset management (DAM) systems like Veeva ProMats, for effortless adoption.

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How does it work?

STEP 1

Content Ingestion

Elmer supports multiple forms of input: text, URLs, PDFs & image files – making it versatile & adaptable to various content types.

STEP 2

Initial Review & Content Annotation

Elmer conducts a preliminary analysis, automatically flagging and annotating sections that may require further attention or revision.

STEP 3

Continuous Learning

With ongoing user feedback & historical interaction insights, Elmer refines its accuracy & aligns with your specific workflows & requirements.

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Want to learn more about ELMER AI? Book a demo today

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USE CASES

AI For MLR Pre-Review

Pre-Clinical Research
Documentation Review
Automate the review of study reports and data to ensure compliance with legal and regulatory standards.
Compliance Verification
Verify that all preclinical study designs and protocols align with regulatory requirements before submission.
Clinical Trials
Trial Protocol Compliance
Assess and confirm that clinical trial protocols adhere to FDA regulations
Informed Consent Oversight
Ensure informed consent forms meet current FDA requirements and legal standards.
FDA Review
Submission Preparation
Thoroughly review clinical trial protocols to confirm compliance with FDA regulations before submission.
Regulatory Filing Review
Cross-reference submissions with FDA checklists, ensuring all required sections and documents are accurate and complete.
Market Launch
Product Labeling & Instructions for Use
Verify that product labels and instructions meet all regulatory standards and are consistent for market release.
Advertising & Promotional Material Review
Ensure promotional materials adhere to regulatory guidelines and align with approved claims.
Post Market
Post-market Surveillance
Assist in managing post-market study obligations, including claims validation and regular reporting to the FDA.
Recall Management
Support the regulatory aspects of potential product recalls or safety alerts, facilitating effective and compliant recall management.
Regulatory Compliance Updates
Provide timely updates on regulatory changes impacting post-market operations and compliance.

Knowledge Sources

FDA Regulations

Federal Food, Drug, and Cosmetic Act

Modernization of Cosmetics Regulation Act
(MoCRA)

FDA Guidance Documents

Code of Federal Regulations (CFR)

Food and Drug Administration Amendments Act (FDAAA)

Fair Packaging & Labeling Act (FPLA)

Monograph System

Drug Enforcement Administration (DEA) Regulations

Consumer Healthcare Products Association

State Pharmacy Laws

Federal Court Decisions

Biologics Control Act and Public Health Service Act

Association of American Feed Control Officials (AAFCO)

Internal Compliance Documents

Regulatory Correspondence

Marketing and Labeling Archives

Company Branding Guidelines

Digital Asset Management Systems

Clinical Trial Data

Legal Precedents and Case Studies

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