NDC Labeler Code Request (replaces Form 2656)
Establishment Registration (replaces Form 2656)
Product Listing/Labeling (replaces Forms 2657, 2658)
GDUFA (Generic Drug User Fee Amendments, 2012) Facility Identification, click here for details…

Structured Product Labeling has been mandated by US FDA which is the only accepted method for electronic submission of drug labeling content for original submissions, supplements and annual reports.

SPL has also started to exchange information needed for other submissions such as Drug Listings, Establishment Registration (ER) and GDUFA Self Registration – now called as eDRL (electronic Drug (Establishment) Registration and (Product) Listing).

This approach is practical and effective in order to streamline submissions for pharmaceutical companies and its marketing within USA. Technically, an SPL is a schema governed electronic document based on the HL7’s (Health Level Seven) Clinical Document Architecture (CDA).

Sarjen pharma team creates and manages Structure Product Labeling (SPL) in XML form by using all the standard parameter as per US FDA requirement with 95% validation guarantee with prompt service.

Sarjen provides complete start to end specialist outsourcing services for variation of SPL submissions such as

  • NDC Labeller Code Request (Human and Veterinary Drugs) and Inactivation
  • ER and De-registration
  • GDUFA
  • Prescription (Human and Animal) Drug Label
  • OTC (Human and Animal) Drug Label
  • Biological Lot Distribution Reports (LDRs) Label
  • Cosmetic Label
  • Dietary Supplement Label
  • Medical Device (Prescription and OTC) Label
  • Bulk Ingredient Label
  • Cellular Therapy Label
  • Vaccine Label
  • Plasma Derivative Label

Our SPL R4 Service Work Flow

Our SPL R4 Service Work Flow

Speed up your submission process using Sarjen’s services. Immaculate accuracy has added innumerable SPLs to Sarjen’s credit. Because Sarjen with its dedicated employees understands the intensive endeavour of getting such approvals. The transition is cumbersome to understand but the precision with which SPLs at Sarjen are prepared is appreciated by all of its clients.