GanLee & Pooyesh Timeline
Category: Other
Updated: 2 Oct 2018
Contributors
Created byNima Caiser
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Events
Place orders for API samplesPens, API, cartridges, stoppers, caps, excipients should be readyReceive SampleGanLee provides checklist for raw materials, excipients, equipment purchasePlace order for Disposable pen (60days lead time)Periods
Contract draft, Finalizing, Hardcopy Signing + Payment + Document ReleasePen Dossier SubmissionGL technical person to Pooyesh for 3 trial batchesCommercial Production Guidance – GL technical person to Pooyesh if necessaryCompany & API Registration with Iran's FDAProduct RegistrationPerform Internal validation; Prepare in-house SOP, DMF, SMFPooyesh technical person training (to GanLee)-Commercialization preparation: packaging material, marketing, etc.
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