August 27, 2025

Beyond the Dossier: What Regulators Really Look For

The file is baseline. Presence, reputation, and alignment carry weight.

The Invisible Criteria

Approval isn’t just about a neat PDF. It’s about perceived reliability: presence, cadence, and a partner that can actually deliver.

Presence & Cadence (Show, Don’t Tell)

  • Attend Q&A sessions with the right local counterpart.
  • Log responses quickly and transparently.
  • Keep weekly touchpoints during critical windows.

The Pre-Briefing Advantage

Meet stakeholders before you file. Align on scope edges, documentation style, and LC expectations. Reduce objections before they’re written.

Submission Rhythm That Works

Fewer objections; faster approvals.

  • Version-controlled dossier with a named coordinator.
  • LC proof and partner roles front-and-center.
  • Anticipate follow-up requests and pre-prepare annexes.
Credibility compounds with presence. Show up consistently, answer questions quickly, and keep your local partner visibly in the loop; that rhythm signals reliability long before the final approval.

Red Flags vs. Green Lights

  • Red: Last-minute letters, unclear activity codes, “paper” partners.
  • Green: Consistent local presence, tidy docs, credible delivery bench.

Bottom Line

Credibility compounds with presence. Act like you’re already delivering—not just applying.

Book Regulatory Navigation support
Interested in more?

Discover our other articles