Service | Life cycle management  
NUVO 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.
Services
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