GENERAL SERVICES

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

Head Office

H/201 Hillmist Harmony, NIBM Road, Pune 48

Mon-Sat 09am-5pm, Sun Closed

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