1. Commissioning the Pre-Audit: You will receive an invoice regarding the fee for the Technical File Pre-Audit.
2. Conducting the Gap Analysis: Upon acceptance, receipt of payment, and all documentation, we will cross-reference your files in detail with current EU GPSR requirements.
3. Evaluation Report: You will receive a detailed report outlining whether your documentation is sufficient or highlighting gaps and additional laboratory tests that are strictly required.
4. Onboarding & Mandate: Following a successful audit outcome (or once documented gaps have been resolved), the official mandate agreement appointing us as your EU Responsible Person for the EU market will be finalized.