Case Study: AI-Driven Support for Regulatory Queries
The Challenge
A small pharmaceutical company faced significant hurdles in getting their new drug approved in multiple countries. The drug was more tolerable than existing options and had the potential to improve the quality of life for many. However, the regulatory approval process required responding to extensive, highly technical queries from various regulatory bodies—a daunting task for a small team.
How AI Helped
Recognizing the complexity of these queries, I designed an AI-powered solution to streamline the process. Using a large language model (LLM), I developed advanced iterative prompts that:
Pulled relevant information from hundreds of pages of technical documents.
Suggested next steps based on regulatory guidelines.
Drafted responses aligned with the company’s historical replies.
Generated arguments and solutions to meet the specific requirements of regulatory bodies.
This approach enabled the company to address queries more efficiently while maintaining accuracy and compliance.
The Solution
To tackle this challenge, I:
Created Information Sheets: I developed concise, query-specific summaries, drastically reducing the time needed to locate critical information.
Iterative AI Optimization: Through carefully crafted prompts, I ensured the LLM provided accurate, cross-referenced responses.
Integrated Validation: I optimised the system to reference regulatory guidelines and sources.
Educated on Limitations: One-off projects come with the possibility of ‘hallucinations’—made-up information from the AI where data is lacking. This is because they do not utilise LLMs that I have specifically trained. I educated the team on this, so that they could use their expertise to ensure the reliability of the responses.
Streamlined Approval Process: The AI-generated drafts significantly sped up the review and approval process for the regulatory team.
This solution was affordable, efficient, and fully compliant with data privacy regulations, as no personal data was involved.
AI as a Tool for Humans, Not a Replacement
This project demonstrated that AI serves as a powerful assistant rather than a replacement for human expertise. The company’s team played a critical role in verifying and refining the AI-generated responses, ensuring they met the highest standards of accuracy and compliance. Their deep understanding of the drug, regulations, and company-specific context allowed them to confidently integrate AI into their workflow.
How I Can Help Your Organisation
Whether you're a small business or a nonprofit, I can help you unlock the power of AI to streamline your workflows and tackle complex challenges. Based on my work in regulatory compliance, here’s how I can support your mission:
Custom AI-Powered Solutions: I can design tailored AI systems to address your specific needs, whether it’s handling regulatory queries, generating reports, or analyzing complex datasets.
Scalable Tools for Long-Term Use: Instead of one-off projects, I can build and optimise platforms or websites that automate these processes, giving you a tool for life. This ensures your team can rely on efficient, AI-driven support without ongoing heavy costs.
Training and Expertise: I can train your team to use AI tools effectively, teaching them how to maximise outputs while maintaining control and oversight.
Affordable, Privacy-Compliant Solutions: I specialise in leveraging cost-effective tools that align with strict data privacy regulations, ensuring your organisation stays secure and compliant.
Empowering Organisations Across Industries
This approach doesn’t just apply to pharmaceutical companies. If your organisation deals with complex processes—whether in healthcare, legal compliance, education, or community initiatives—I can create AI solutions tailored to your needs. From automating repetitive tasks to providing actionable insights, these tools can help you focus on what matters most: delivering value to your clients and stakeholders.
Ready to explore how AI can empower your mission? Let’s talk!