AI Driven Workflow for Regulatory Compliance in Pharma Naming

Regulatory Compliance Check for AI-Generated Pharmaceutical Names

1. Initial Name Generation

1.1 Define Naming Criteria

Establish specific criteria for pharmaceutical names, including uniqueness, memorability, and relevance to the product.

1.2 Utilize AI Naming Tools

Employ AI-driven naming tools such as NameRobot or Namify to generate a list of potential names based on the defined criteria.

2. Preliminary Screening

2.1 Conduct Trademark Search

Use AI tools like TrademarkNow or Markify to conduct a preliminary trademark search to ensure the names are not already in use.

2.2 Assess Linguistic Compatibility

Utilize AI-driven language analysis tools such as TextRazor to evaluate the names for linguistic appropriateness across different languages and cultures.

3. Regulatory Compliance Assessment

3.1 Review Regulatory Guidelines

Consult relevant regulatory bodies such as the FDA or EMA for naming regulations and guidelines.

3.2 Implement AI Compliance Tools

Incorporate AI compliance tools like Compliance.ai to analyze generated names against regulatory requirements.

3.3 Risk Assessment

Utilize AI risk assessment tools to identify potential legal and compliance risks associated with each name.

4. Stakeholder Review

4.1 Internal Review Process

Engage cross-functional teams (marketing, legal, R&D) in reviewing the shortlisted names using collaborative platforms like Slack or Trello.

4.2 External Feedback

Gather feedback from external stakeholders, including healthcare professionals and focus groups, using survey tools such as SurveyMonkey.

5. Final Approval

5.1 Compile Final List

Create a final list of names based on the feedback and compliance checks.

5.2 Submit for Regulatory Approval

Submit the final names to regulatory authorities for approval, ensuring all necessary documentation is included.

6. Monitoring and Compliance Maintenance

6.1 Continuous Monitoring

Implement AI monitoring tools to continuously track compliance status and any changes in regulatory guidelines.

6.2 Periodic Review

Schedule regular reviews of the naming process and compliance checks to adapt to evolving regulations and market needs.