Regulatory Compliance Management

Effective Early Access Programs (EAPs) require rigorous regulatory compliance management across all markets. At MedWatch Consulting, we align program design, safety processes, and documentation with FDA Expanded Access guidance, EMA expectations, and applicable national regulations, including GDPR.

We define roles and responsibilities, set up compliant data privacy and consent pathways, and ensure inspection-ready records—covering adverse event handling, periodic updates, and communications with authorities. Our approach provides end-to-end traceability and a clear audit trail.

With structured governance and continuous oversight, your program remains transparent, compliant, and patient-centric from initiation through close-out.

Contact us