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May 31, 2020
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GanLee & Pooyesh Timeline
Created by
Nima Caiser
⟶ Updated 2 Oct 2018 ⟶
List of edits
Timelines by
Nima Caiser
:
2 Oct 2018
0
0
45
Pooyesh Suggestion
Comments
Events
Place orders for API samples
Pens, API, cartridges, stoppers, caps, excipients should be ready
Receive Sample
GanLee provides checklist for raw materials, excipients, equipment purchase
Place order for Disposable pen (60days lead time)
Periods
Contract draft, Finalizing, Hardcopy Signing + Payment + Document Release
Pen Dossier Submission
GL technical person to Pooyesh for 3 trial batches
Commercial Production Guidance – GL technical person to Pooyesh if necessary
Company & API Registration with Iran's FDA
Product Registration
Perform Internal validation; Prepare in-house SOP, DMF, SMF
Pooyesh technical person training (to GanLee)-
Commercialization preparation: packaging material, marketing, etc.
