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  • Structured Product Labeling (SPL R4)
  • eCTD Dossier Preparation and DMF Preparation(FOR FDA and EUROPE)
  • 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
  • Providing guidance for ESG account setup and for successful submission
  • Collect content information from client, Convert label to SPL ie XML format, validate the SPL and then provide it to the client
  • Patentability report
  • Patent application drafting
  • Patent filling and prosecution