Transforming Regulatory
Submissions using Generative
AI : A Case Study on Enhancing
Speed, Efficiency and Quality

Transforming Regulatory Submissions with GenAI

Our client’s requirement

Client Company’s Regulatory Affairs teams worldwide face a significant volume of Health Authority Questions (HAQs). These questionnaires, crucial for timely regulatory submissions, can be in various formats – structured or unstructured – and require responses within tight deadlines. The traditional manual processing method was becoming increasingly unsustainable due to:

  • Inefficiency: Manual processing is time-consuming and limits the team’s capacity to handle the high volume of HAQs.
  • Error-proneness: Manual processes are more susceptible to human error, potentially impacting submission accuracy.

Our approach

Excelra partnered closely with a client to tackle their regulatory submission challenges. Through a collaborative effort, we gained a deep understanding of their existing processes, infrastructure, pain points, subject matter expert (SME) perspectives, and business objectives.

Tailored Generative AI Solution for Streamlined Submissions

Leveraging this comprehensive understanding, Excelra proposed an AI-powered solution specifically designed to address the client’s needs. We fostered continuous collaboration with the client’s engineering team, business team, and SMEs throughout the development process. This collaborative approach ensured:

1.Incorporation of Valuable Feedback: We continuously incorporated the client’s feedback to refine and improve the solution.

2.Seamless Integration: The solution was designed for seamless integration with the client’s existing data platform, minimizing disruption and maximizing efficiency.

Agile Development for Iterative Improvement

An agile development approach facilitated iterative improvements to the solution. This ensured we delivered tangible outcomes with every release, allowing for continuous progress and alignment with the client’s evolving needs.

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