FDA HL7 - SPL Submission Services
Saxon Interglobal Associates offers HL7 - SPL Submission Services for the API and FDF market segments.
We can identify your FDA SPL Submissions regulatory Compliance requirements and help you create a scalable strategy to plan, and implement the most cost-effective and risk-averse practices for your SPL Submissions.
We help firms avoid costly customs holds or FDA Regulatory Compliance warnings by risk management of SPL Submissions.
SIA maintains an ESG gateway to service your FDA HL7 - SPL Submission requirements for:
–GDUFA Self-Identification
–Establishment Registration
–NDC Labeler Code Request or Changes
–Drug Listing
–Blanket No-Change Drug Listing
–Drug Discontinuation (required under 21CFR)
–NDC Configuration Change Projects
–GDUFA User Fee Payment services or guidance