Guidance related to Regulatory and Clinical Compliance

Guidance related to Regulatory submission compilation

Building Regulatory Operation department (from the ground up)

• Drafting Procedure Documents (SOPs, Work Instructions)

• Business requirements and business cases assessment

• Software Selection

• Gateway setup

Support submission deadline (typically lasts 3-4 weeks)

• Operational guidance

• System troubleshoot

• Last-minute changes

• Agency Gateway issues​