Life cycle management - Dossier

NUVO provides full assistance in life cycle management of a product across the Globe for our clients.

We perform the complete writing of the submission, its eCTD publishing and submission to regulatory agency. We also maintain the renewals and reregistraion tracking and perfom it without to its anniversary date.

  • Dossier writing services for the post approval filings and submissions
  • eCTD Publishing services
  • Dossier Submission Services through Submission portals
  • US agent and drug listing Services for maintaining the registrations
  • Indian agent services

Life-cycle management EU Marketing Authorrisation Application (MAA) for the Marketing authorization holder (MAH): 

  • 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 eCTD
  • Line extension applications
  • Guidance and assistance in grouping of variations and worksharing.
  • Preparation and submission of renewal application for EU.
  • Maintaining complete lifecycle of the product.
  • Brexit support
  • Change in MAH
  • Preparation of Amendment to clinical overview (ACO) for renewal of the EU MAA dossier.

Life-cycle management ANDA’s: 

  • Assistance in categorizing the changes into the type for US FDA.
  • Preparation and submission of changes to approved NDA or ANDA :
    • Change being effective from Day 0 (CBE -0) Supplement
    • Change being effective after Day 30 (CBE-30) Supplement
    • Prior Approval Supplement (PAS)
    • Annual report, Amendments and supplements to US FDA

Life-cycle management of Rest of the world Dossier:

  • Changes to the exiting dossier
  • Renewal filing and maintaining the same
  • Re-registration
  • Query responses to the submissions

Maintainance of US FDA adminstrative filings for its changes and annual registrations :

  • Annual filing of Establishment Registration (ER)
  • Drug listing certification (DLC)
  • Self Identification filing

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