Highlights

The app automates the review process for pharmaceutical marketing materials, reducing manual labor and significantly speeding up time-to-market for drug products.

By integrating Natural Language Processing and image recognition, the solution improves accuracy and ensures that all necessary disclaimers and regulations are met, while also allowing for easy collaboration with version control.

The automated system accelerates compliance checks from months to days, minimizing human errors and providing a competitive edge for faster drug approvals.

The client is a startup focused solely on developing a cutting-edge web application that automates the compliance checks for marketing materials in the pharmaceutical industry. Their primary sponsor is a major pharmaceutical company that required a faster, more efficient way to ensure that drug-related materials adhered to regulatory standards. The sponsor needed a solution that could reduce time, cost, and errors in the approval process of marketing materials.
Employees: 10+
Industry: Software Development, Healthcare
Sector: Compliance Automation for Pharmaceuticals

Primary Objectives

  • Automate Compliance Checks:

    The startup’s goal was to create a system that automatically verifies whether marketing materials comply with regulatory requirements, reducing reliance on manual reviews.

  • Reduce Time-to-Market for Pharmaceuticals:

    By speeding up the review process, the startup aimed to help their sponsor bring drug products to market faster.

  • Enhance Accuracy:

    The solution needed to eliminate human error, ensuring that all necessary claims and rules were followed precisely.

  • Support Collaborative Work:

    The application required functionality for multiple users to collaborate on reviewing and editing the same document, while maintaining version control.

Challenge

The startup faced a major challenge in creating an application that could address the complex regulatory requirements for marketing materials in the pharmaceutical industry.

Mandatory Disclaimers and Branding:

Pharmaceutical marketing materials must include specific disclaimers, like “consult a doctor,” and the correct usage of trademark symbols. Ensuring these requirements are consistently met posed a significant manual challenge.

Maintaining Factual Integrity

All marketing content had to avoid subjective or promotional language, strictly adhering to facts. This added complexity to the review process, as it required careful scrutiny of every detail.

Complex Regulatory Requirements:

The extensive and detailed regulatory frameworks made the review process cumbersome, often taking up to a year to complete, causing delays in product launches.

Scalability and Usability:

The startup needed to create a solution that not only handled the complex regulatory requirements but was also user-friendly and scalable for large pharmaceutical companies to ensure broad application and ease of use.

How Academy SMART Helped

Academy SMART provided the startup with a full development team, including Senior Python Developers, React Developers, DevOps Engineers, Business Analysts, and Project Managers. Working closely with the startup, the team helped design and implement a web application that automates the review process.

User-Friendly Web Interface:

The web application, built with React, allows users to upload any type of marketing material—such as brochures or advertisements—and run them through an automated compliance check.

Automated Review System:

The application scans both text and images to ensure they meet all regulatory requirements. The system checks for the presence of mandatory disclaimers and branding elements, and validates that the language is factual and compliant.

Text and Image Analysis:

The platform uses Natural Language Processing (NLP) models and image recognition to evaluate documents. It ensures that the text aligns with regulatory guidelines and that images are used appropriately.

Comprehensive Rules Engine:

The application’s core is a rules engine that stores all the necessary claims and regulations, automatically checking the materials for compliance and flagging any issues.

Collaboration and Version Control:

Multiple users can work on the same document simultaneously, and version control allows for tracking changes and ensuring consistent compliance across different versions.

Security and Integration:

Built on Microsoft Azure, the product ensures top-tier security while also offering easy integration with the sponsor’s existing systems.

Business Impact

  • Accelerated Compliance Review

    The automated system dramatically reduced the time required for reviewing marketing materials, from several months to just days. The system also reduced the need for extensive legal reviews. This allowed the sponsor to move drug products to market more quickly, reducing delays and gaining a competitive edge.

  • Elimination of Human Error

    By automating the review process, the system minimized the risk of human errors, such as missing required disclaimers or overlooking regulatory guidelines. This increased the sponsor’s confidence in the accuracy of their marketing materials.

  • Enhanced Collaboration

    The platform’s collaborative features made it easy for teams across departments to work together on reviewing and editing materials. The built-in version control ensured that all stakeholders were working with the most up-to-date and compliant version of each document.

Summary

Technologies
Reacr
Python
NLP
Microsoft Azure
PDF Parsing
Image Recognition
Flask
FastAPI
SQLAlchemy
AsyncIO
Pandas
Services
Web Application Development
Machine Learning
Project Management
AI Integration
Business Analysis
DevOps
Team
Python Developers
React Developers
DevOps Engineer
Business Analyst
Project Manager

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