Overview
Regulatory submissions in the life sciences industry require rapid and accurate responses to queries from health authorities. As the volume of Health Authority Questions (HAQs) increases globally, regulatory affairs teams face growing pressure to respond quickly while maintaining compliance and data accuracy.
Excelra partnered with a leading global biopharmaceutical company to transform their regulatory submission workflows using Generative AI and advanced data management technologies. By leveraging Scientific Informatics, Data Curation Services, and AI-driven analytics, Excelra developed a scalable solution that automated the processing of regulatory queries, reduced response times, and improved the quality of submission documents.
Our client
The client is a global biopharmaceutical company operating in over 100 countries, with a diverse portfolio including vaccines, specialty medicines, and therapies across multiple therapeutic areas such as infectious diseases, HIV, respiratory/immunology, and oncology. Their regulatory affairs teams manage large volumes of regulatory documentation required for global product approvals and lifecycle management.
Client’s challenge
The client’s regulatory affairs teams were receiving an increasing number of Health Authority Questions (HAQs) that required timely responses during regulatory submissions.
These queries presented several challenges:
- HAQs arrived in both structured and unstructured formats
- Responses were required under strict regulatory timelines
- Manual processing workflows were time-consuming and inefficient
- Increased risk of human error affecting regulatory compliance
- Difficulty locating relevant information across large document repositories
As described in the case study document, manual workflows were becoming prohibitively slow and error-prone, making automation essential.
Client’s goals
The client sought to:
- Automate responses to Health Authority Questions
- Reduce time spent searching and compiling regulatory documentation
- Improve accuracy and consistency of regulatory submissions
- Enable faster responses to regulatory authorities
- Streamline global regulatory operations using AI technologies
Our approach
Process assessment and collaboration
Excelra worked closely with the client’s regulatory teams, engineering teams, and subject matter experts to understand their workflows, infrastructure, and business objectives. This collaborative assessment ensured the solution aligned with operational needs.
Tailored generative AI solution
Based on these insights, Excelra developed a Generative AI-powered solution capable of automatically generating draft responses for regulatory queries using information from the client’s document repository.
The system leveraged a large corpus of regulatory documentation to produce contextually relevant responses supported by source references.
Seamless integration with existing systems
The AI solution was designed for seamless integration with the client’s existing data platform, ensuring minimal disruption to existing workflows while maximizing operational efficiency.
Agile development and continuous improvement
Excelra adopted an agile development methodology, allowing iterative improvements based on continuous client feedback. This approach ensured each release delivered measurable improvements and remained aligned with evolving regulatory requirements.
Our solution
The AI-powered solution significantly improved the efficiency of regulatory submission workflows.
Key Outcomes
- 50% Reduction in drafting time
The solution automatically generated draft responses to regulatory queries within seconds, reducing the time required to prepare responses by approximately 50%. - 40% faster document retrieval
AI-enabled search capabilities allowed regulatory teams to locate relevant documentation 40% faster than traditional methods. - 30% Reduction in manual effort
Automated classification and extraction of HAQ objects reduced manual processing effort by up to 30%. - Improved visibility and insights
The system provided real-time insights into regulatory question trends and open queries across product portfolios, improving operational transparency.
Conclusion
Excelra’s Generative AI-driven regulatory submission solution enabled the client to streamline complex regulatory workflows and significantly improve operational efficiency. By automating the generation of responses to Health Authority Questions and integrating AI-powered document search capabilities, Excelra helped the client accelerate regulatory submissions while improving accuracy and compliance.
This project demonstrates how AI-driven scientific informatics and data management solutions can transform regulatory operations across the life sciences industry.
For additional insights into Excelra’s capabilities, explore more case studies or learn about Excelra’s AI solutions for life sciences.
