Challenge
A client submitted numerous small, regionally fragmented technical changes across markets, resulting in duplicated reviews, inconsistent outcomes and extended cumulative approval timelines that delayed commercial harmonization and complicated supply planning.
Approach
We assessed change types across regions to identify opportunities for legitimate bundling, prioritized changes that would benefit most from consolidation, and prepared consolidated dossiers with harmonized supporting data and risk assessments. We worked with regulatory leads to sequence bundled submissions to align with key supply milestones and trained TPMs on bundling criteria and tradeoffs.
Impact
Bundled filings reduced duplicated regulator interactions, lowered cumulative review cycles for grouped changes, and improved synchronization of approvals across priority markets—reducing planning complexity and enabling more predictable supply timing for downstream operations.
