U.S. FDA Drugs

Establishment Registration & Listing

Docent Pharma has extensive experience of convening and creating U.S.FDA compliant & validated SPL files (XML). SPL Conversion Services include the creation of SPL submission package to U.S.FDA for the following types of submission and secure transmission to U.S.FDA. will meet company needs for eDRLS (Electronic Drug Registration and Listing Systems).

  • NDC/NHRIC Labeler Code Request
  • Drug Establishment Registration
  • Drug Listing

The benefit of Docent Pharma’s SPL Conversion Services;

  • Fast, Accurate. and Cost-Effective Service
  • Reduces Expenses Related to In-House SPL Software & It’s Maintenance and Staff
  • Performing In-Depth SPL Validation for U.S.FDA Compliant SPL Submission
  • Checking Format Data Values ( D-U-N-S Number, FEI Number, Labeler Code, etc )
  • Lifecycle Management for SPL Submission
  • Data Protection through Our Secure Environment

Docent Pharma Can Assist :

  • Human & Animal Drug
  • Rx & OTC Drugs
  • Bulk Drug/Active Drug Substance Manufacturer
  • Medical Gas Transfiller
  • Domestic/Foreign Manufacturers
  • Own/Private Label Distributor
  • Contract Testing Lab
  • Repacker/Relabeler

    Additional Assistance :

  • Procurement of D&B D-U-N-S® Number
  • Label Review & Compliance for U.S. FDA Submission