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SPL DIRECT

Conversion & Migration Services | Fast & Efficient | 100% Validation Guarantee | Electronic Submission Service [US]


From Source to Gateway: Compliance & Regulatory Services for Structured Product Labeling (SPL) and ACA6004

  • Establishment Registrations SPL creation and annual updates
  • Blanket No Changes Certification for Product Listing
  • Labeler Code Request SPL creation
  • Drug Listing/Content of Labeling SPL creation
  • Lot Distribution Report SPL creation
  • Drug for Further Processing
  • Generic Drug Facility Identification Submission
  • Identification Of CBER-Regulated Generic Drug Facility
  • Risk Evaluation and Mitigation Strategies(REMS)
  • ACA6004 [Drug Sample Reporting ] conversions to XML
  • Gateway submissions

  • Coming soon: Salvaged Animal Drug, Blood Establishment Registration & Product Listing, Blood Establishment Registration & Product Listing Change in Information, Human Cell and Tissue Establishemnt Registration & Product Listing, Human Cell and Tissue Establishemnt Registration & Product Listing Change in Information Human Compounded Drugs, Animal Compound Drug, Wholesale Drug Distributor / Third Party Logistics Facility Report


i4i's SPL Creation & Submission Services

Solving Today's Regulatory Issues

In October 2005, the FDA officially adopted the HL7 SPL (Structured Product Labeling) standard as the mechanism for exchanging product and facility information. Pharmaceutical and health care organizations are required to submit their product information electronically, as XML documents that conform to the HL7 SPL specification.

As an XML pioneer and leading contributor to the development of the SPL standard, i4i possesses an intricate understanding of the FDA requirements. Thanks to this knowledge, i4i's products and services offer unparalleled speed and accuracy in the creation and migration of labeling documents to the SPL format.

With SPL DIRECT, i4i can assist with any part of the SPL creation process, ranging from full outsourcing to in-house conversions. Regardless of the kind of products you manufacture or distribute, we can transform your labels from any source format to SPL. i4i is also well positioned and offers XML conversions for the ACA6004 submissions[Drug Sample reporting].

i4i Advantage at all levels

i4i's conversion services are delivered by experienced and knowledgeable regulatory specialists, using our industry leading content authoring application, A4L.

The combination of the A4L platform, experienced personnel, and a process-oriented testing methodology ensures quality and compliance. A4L ensures XML validation against the required schema files that are provided by the SPL Implementation and Guidance documentation.

In-depth validation is performed using the FDA's SPL validation rules, including OTC Monograph/CRF rules, Medication Guide validation, required content of labeling sections, and UNII code and moiety validation—to ensure that the SPL will be submission ready.

These processes support all SPL requirements and standards, and ensure the validity and acceptance of your labels.

Methodology and Process

Conversion Methodology
Our conversion cycle methodology follows these steps:

  1. Analysis of source data.
  2. Review of inconsistencies with client.
  3. Creation of an FDA SPL.
  4. Validation and quality assurance of the SPL.
  5. Creation of the requested file format(s) (SPL, Word, PDF, etc.).
  6. Delivery of the SPL submission package, by uploading it to our secure site—for client retrieval, review, and acceptance.
  7. Submission through gateway.
  8. Verify posting [where applicable]. Close conversion ticket.

SPL DIRECT ensures our team of regulatory specialists are ready when you need them, with SPL creation and submission services, direct to the FDA or your inbox! We are ready to assist you with all your labeling and listing needs. We can help manage the entire process, or fill in any area you'd like help with.

The end result is a compliant set of labels that can be repurposed to various stakeholders across your organization.

 

Ask us what we can do for you.