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FDA · ESG
ESG gateway submission and acknowledgement tracking.
Every SPL submission has to clear the FDA Electronic Submissions Gateway (ESG) — and survive multiple acknowledgement stages (MDN, ACK1, ACK2, ACK3). Alnexia operates the gateway hand-off and tracks every receipt to closure.
Capabilities
What we deliver
WebTrader / AS2
Submission via WebTrader for low-volume programmes or AS2 for high-volume automated transmission.
Pre-submission validation
Schematron and FDA business rules cleared before transmission.
Acknowledgement tracking
MDN, ACK1, ACK2 and ACK3 captured, with re-submission on failure.
DUNS & gateway identity
Establishment DUNS, gateway certificates and account hygiene managed.
Evidence pack
Per-submission archive: payload, receipts, validator log, narrative.
Deliverables
Artefacts you receive
- ESG-ready SPL package
- Transmission log & receipts
- Evidence pack archive
References & standards
Sourced from regulators and industry leaders
- FDA — ESG — U.S. FDA
- FDA — SPL acknowledgements — U.S. FDA
Ready to scope this work?
Talk to an Alnexia specialist about timelines, deliverables and pricing — no obligation.
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