Regulatory Submissions, Built Right the First Time
Every inconsistency in submission data adds risk and delay. Bayer now builds submissions on one governed source of product, reference, and medical data, so filings move faster and hold up to scrutiny.
Challenge
A regulatory submission pulls data from every stage of the drug lifecycle. When definitions and terminologies varied across teams, assembling a filing meant reconciling inconsistencies by hand: slow, costly, and risky when regulators are involved.
Solution
Bayer built a governed context layer for product, reference, and medical terminology: one trusted source spanning the lifecycle. Submission data is consistent and traceable by design, so teams compile filings instead of reconciling them.
Technical approach
- One canonical model of product, reference, and medical terms, with validation and lineage enforced in the data
- AI-drafted, expert-approved, and kept governed and current
- Integrates with Argus and Veeva
Results
- Submissions 30-50% faster, built on consistent data end to end
- First-pass approvals up, from traceable and standards-aligned data
- Compliance risk down, because every team shares one trusted source