From filing cabinets to “ask the submission”
Regulatory and medical affairs were drowning in past submissions and guidelines. Finding the right reference used to take weeks.
Regulatory and medical affairs were drowning in past submissions and guidelines. Finding the right reference used to take weeks.
Every new drug submission leaned on prior art: old CTDs, responses to questions, and regional guidelines. Specialists knew the content existed but had no way to search it semantically. They copied paragraphs from PDFs and hoped nothing was missed. One missed reference could mean a delay or a finding.
We built a secure, internal RAG application. It runs in their own cloud, ingests only approved documents (CTDs, SOPs, regulatory correspondence), and uses embeddings and retrieval so users can ask questions in plain language. Answers cite exact sources and snippets. Access is logged; data never leaves the boundary. It’s built for GxP-minded teams, not generic ChatGPT.
What used to take days of digging now takes minutes. Medical and regulatory writers use it to draft sections and check consistency. Quality and compliance signed off because the system is auditable and contained. The team is now expanding the corpus to include more regions and submission types.