Stepup helps in life cycle management of a product in all the countries for our clients.

  • Assistance in categorizing the changes into the type of variation it is for EU.
  • Preparation and submission of Variation applications :
    • Type IAIN
    • Type IA
    • Type IB
    • Type II
  • Preparation of Variation application in NeeS and eCTD
  • Preparation and submission of renewal application for EU
  • Maintaining complete lifecycle of the product
  • Assistance in categorizing the changes as per guidance for US
  • Preparation and submission of changes to approved ANDA :
    • Change being effective from Day 0 (CBE -0)
    • Change being effective after Day 30 (CBE-30)
    • Prior Approval Supplement (PAS)
    • Annual report, Amendments and supplements to US FDA
  • Maintaining licenses across globe.
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