Comprehensive FDA Drug Listing & SPL Compliance Solutions
Axentra specializes in providing expert services for FDA compliance in drug listing and SPL submissions. Our solutions include fsvp & quality audits to ensure your drug products meet stringent FDA requirements. From initial NDC structure design to annual certifications, we manage your compliance lifecycle. With our fsvp & quality audits and expertise, you can confidently maintain regulatory compliance and avoid costly errors. Partner with Axentra for reliable and accurate drug compliance support.
Complete Drug Listing & SPL Lifecycle Management
Axentra manages every stage of FDA Drug Listing for prescription, OTC, API, and repackaged drug products—ensuring accurate, compliant, and fully validated SPL submissions. We design correct NDC structures, maintain labeler code integrity, prepare initial listings, and manage all required updates for formulation changes, labeling revisions, package alterations, commercial status changes, and annual certifications. Each SPL is validated for structure, terminology, and content to meet FDA’s electronic submission standards and avoid the errors that often lead to misbranding citations or import holds.
Complete Drug Listing & SPL Lifecycle Management
Axentra manages every stage of FDA Drug Listing for prescription, OTC, API, and repackaged drug products—ensuring accurate, compliant, and fully validated SPL submissions. We design correct NDC structures, maintain labeler code integrity, prepare initial listings, and manage all required updates for formulation changes, labeling revisions, package alterations, commercial status changes, and annual certifications. Each SPL is validated for structure, terminology, and content to meet FDA’s electronic submission standards and avoid the errors that often lead to misbranding citations or import holds.
NDC Strategy, Labeler Code Management & Compliance Accuracy
Foreign manufacturers frequently struggle with the technical rules behind NDC assignment, labeler code utilization, and the alignment of establishment data with marketed product details. Axentra eliminates this risk by managing NDC planning, preventing code collisions, ensuring correct packager associations, and aligning every SPL with the facility’s Establishment Registration and FEI data. Our expertise extends to correcting legacy listings, resolving inactive or rejected SPLs, and ensuring your products appear accurately in FDA’s NDC Directory and Drug Listing database at all times.
Inspection-Ready Labeling Compliance & Post-Market Oversight
Beyond SPL creation, Axentra ensures your drug listings fully support FDA inspection expectations by aligning SPL text with your approved labeling, promotional claims, and change-control documentation. We proactively monitor FDA guidance, labeling updates, therapeutic class requirements, and electronic submission standards to determine when your listings require revision. Our integrated approach links SPL compliance with facility registration, labeling compliance, and import readiness—providing continuous oversight and reducing regulatory and operational risk across the product lifecycle.
Why Choose Axentra for Drug Listing & SPL Compliance
Expert NDC & Labeler Code Management That Prevents Costly Errors
We design correct NDC structures, maintain labeler code integrity, and prevent code conflicts or misalignments—reducing the risk of listing rejection, import delays, or database inconsistencies.
Fully Validated, FDA-Compliant SPL Submissions Across the Entire Product Lifecycle
Every SPL is technically validated for structure, terminology, dosage form coding, packager association, and regulatory category—ensuring your listings meet FDA’s strict electronic submission standards and remain accurate through all formulation, label, and packaging updates.
Integrated Oversight Connecting SPL, Registration, Labeling & Post-Market Compliance
Axentra links your SPL filings with establishment registration, labeling compliance, and change-control requirements—creating a unified, inspection-ready system that minimizes regulatory risk and keeps your products visible and compliant in FDA’s Drug Listing database.