RegAffairs AI

What Is RegAffairs AI?

RegAffairs AI is a web-based regulatory research platform that helps regulatory affairs and compliance professionals find requirements across countries and industries. It uses AI to search official regulatory sources and answer questions with citations to relevant provisions, enabling users to trace findings back to original documents and verify the information. By bringing regulatory information into one searchable platform, it helps teams research requirements without manually navigating multiple websites. The vendor reports coverage across various industry verticals, with regulatory datasets updated weekly. Data is processed and stored in the EU by default, and the platform supports regulatory research rather than providing legal advice.

What Is RegAffairs AI Best For?

RegAffairs AI's key feature is its citation-backed regulatory research. The platform searches official sources and links its answers to specific regulatory provisions, so users can verify the rules behind each response. It also records the research process to show how it reached a finding. Compliance teams can review this record to understand the basis for an answer before using it in regulatory assessments or internal documents.

How Much Does RegAffairs AI Cost?

RegAffairs AI pricing starts at $100/month for the Pro plan, which includes unlimited regulatory queries, deep research with priority speed, full conversation history, and access to regulatory sources across available jurisdictions. Users can cancel anytime without a contract or cancellation fee. Other available plans include:

• Free: $0/month
• Enterprise: Custom pricing

Other additional costs that may influence the total price may include:

• Integration And Implementation: A one-time budget of $1,000–$5,000 may be needed to connect RegAffairs AI with existing regulatory or business systems. The final cost will depend on the complexity of the integration
• Internal Data Onboarding: Preparing internal documents and configuring access to proprietary data could add $500–$3,000 in initial costs
• Staff Training And Onboarding: Training expenses may range from $300–$1,500, depending on team size and the level of guidance required
• Additional User Seats: If Enterprise access is billed/user, each additional seat could cost $20–$100/month

Disclaimer: The pricing is subject to change.

RegAffairs AI Integrations

RegAffairs AI can be used as a standalone web platform or connect to AI tools teams already use. These include:

• Claude Anthropic
• ChatGPT
• MCP server
• API

How Does RegAffairs AI Work?

RegAffairs AI lets users research regulatory questions and trace answers back to official sources. Here is how the process typically works:

• Log in to your RegAffairs AI account through a web browser
• Enter a question about a product or substance in plain language
• Let the platform search its indexed regulatory sources for applicable requirements
• Review the research trail to see which documents support the answer
• Open the citations to check relevant articles or passages in official documents
• Compare the findings with the original text to determine how they apply to your situation
• Ask follow-up questions to clarify requirements or explore regulations in other markets
• Use the MCP integration to access RegAffairs AI through compatible AI tools

Who Is RegAffairs AI For?

RegAffairs AI software serves professionals working in these industries:

• Pharmaceuticals
• Medical devices
• Food
• Environment, Safety and Health (ESH)
• Pesticides
• Fashion and textiles
• Cosmetics

RegAffairs AI Use Cases

Based on RegAffairs AI’s current capabilities, we identified five scenarios where the platform could support regulatory professionals in finding applicable rules and tracing answers to official sources:

Chemical Manufacturers Checking REACH And CLP Requirements

Chemical manufacturers selling in Europe must check whether their substances meet REACH and CLP requirements. This includes confirming registration status and checking for restrictions or harmonized hazard classifications. RegAffairs AI helps teams find the required entries and updates in official sources. Its citations also let them trace each finding to the original regulatory text before making changes to product documents or assessing market requirements.

SDS Authors Verifying Hazard Classifications

When preparing a safety data sheet (SDS), authors need to confirm hazard classifications, applicable limits, and other regulatory details. RegAffairs AI helps them find official classifications and trace findings to their original sources. This can make it easier to check substance entries or identify changes in regulations. A qualified professional must still review the completed SDS to confirm its accuracy.

Cosmetics Brands Assessing Ingredient Restrictions Before Launch

Cosmetics brands preparing to enter a new market must check whether their ingredients are permitted and whether any restrictions or concentration limits apply. Regulatory specialists can use RegAffairs AI to research ingredient requirements in different jurisdictions and find the official provisions relevant to a formulation. This can help teams gather the necessary evidence before making decisions about formulations or market entry.

REACH Only Representatives Handling Client Substance Queries

RegAffairs AI helps Only Representatives research regulatory requirements on behalf of non-EU manufacturers. They can check substance registrations and restrictions under REACH, CLP, and UK REACH. The findings can then support client reports and correspondence with links to the relevant sources. Representatives must still interpret the results and ensure each client meets its regulatory obligations.

Regulatory Affairs Managers Preparing Briefings On New Rules

When a regulator amends a requirement, compliance managers need to determine what has changed and which products or processes may be affected. They first need to locate the amendment and review the supporting regulatory text before preparing an internal briefing for legal, quality, or product teams. RegAffairs AI can help with this research by providing cited findings that teams can verify before using them to guide compliance decisions.

Is RegAffairs AI Right For You?

RegAffairs AI is designed for regulatory affairs professionals who need to check legal requirements before making business decisions. It searches for official sources to answer questions about product classification and authorization. Users can also investigate limits that apply to specific substances. Each answer includes references that help them verify the findings.

The platform supports regulatory research instead of full compliance management. It helps users find and understand applicable rules. However, businesses that need to assign compliance tasks or track their completion may need another tool. The same is true for teams that manage audits or require formal document approval.

The software stores and processes data and does not use user queries and uploaded files to train its models. Users can request the deletion of their account data and conversations.

RegAffairs AI may suit professionals who need to research regulations and verify answers against official sources. It may be less suitable for organizations that require advanced access controls or formal security certifications.

Still doubtful if RegAffairs AI is the right fit for you? Get in touch at (661) 384-7070, and we will help you make an informed decision.