Life Cycle Management

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 IA_IN
  • 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.