An AI Toolkit for Regulatory Affairs: Cutting Document Review Time for a Pharma Consultancy

‍‍

‍

Business Context

‍

‍

A UK-based regulatory affairs consultancy with around 110 staff supports pharmaceutical and biotech companies to prepare and submit applications for drug approval in the UK, EU and US.

‍

Consultants spend significant time manually checking submission documents against formatting requirements and extracting specific data points  before transferring them into standardised templates. E.g.  From clinical study reports running to thousands of pages

‍

‍

‍

‍

The Passion Labs Approach

‍

‍

Passion Labs designed a multi-agent conversational toolkit, orchestrated by a routing agent that dispatches each request to a specialised tool.

‍

• A submission-readiness checker runs deterministic, code-based checks against PDF formatting rules, with an LLM layer for content-based checks. 
• A study data extraction tool uses a hierarchical summarisation strategy to process long clinical and non-clinical reports. Thereby, returning structured, citation-linked extracts mapped to source pages. 
• A proposal drafter searches the firm's case study and template libraries to generate first-draft client presentations from a scoping call transcript. 

‍

The system is designed to run entirely within the client's own Azure tenant, keeping all data in-tenant throughout.

‍

‍

Impact & ROI

‍

‍

‍

Projected impact once deployed:

‍

• 80% reduction in manual submission-readiness checking time per document
  
  
• 60% faster time-to-first-draft for clinical study data extraction
  
  
• 70% reduction in first-draft assembly time for client proposals
  
  
• Full data sovereignty maintained through in-tenant deployment

‍