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April 1, 2024
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Pooyesh Suggestion
Created by
Nima Caiser
⟶ Updated 2 Oct 2018 ⟶
List of edits
Timelines by
Nima Caiser
:
2 Oct 2018
0
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251
GanLee & Pooyesh Timeline
Comments
Events
GanLee provides checklist for raw materials, excipients, equipment purchase
Place orders for API and Pen sample
Pooyesh technical person training (to GanLee)-
Place order for Disposable pen (60days lead time)
Pens, API, cartridges, stoppers, caps, excipients should be ready
Periods
Contract draft, Finalizing, Hardcopy Signing + Payment + Document Release
Company & API Registration with Iran's FDA
Internal validation; Prepare in-house SOP, DMF, SMF
Product Registration
Trial Batch and Stability Testing
Commercialization preparation: packaging material, marketing, etc.