LCM-DMF

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

We perform the complete writing of the submission, its eCTD publishing and submission to regulatory agency.

 

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

 

Life-cycle management of US Drug master File (DMF): 

  • Annual reports preparations, eCTD publishing and filing with US FDA
  • Amendments preparations, eCTD publishing and filing with US FDA
  • Query response to support the amendment filing to safe approval
  • DMF updating and its complete revision.
  • US DMF LCM support for :
    • Type –II DMF for API, Intermediate and formulation.
    • Type –III DMF for Packaging materials and its components.
    • Type –IVDMF for Excipients, colorant, flavor, essence, or material used in their preparation

 

Life-cycle management of Active Substance master File (ASMF) and CEP: 

  • ASMF revisions preparations, eCTD publishing and filing with US FDA
  • Query response to support the amendment filing to safe approval
  • ASMF updating and its complete revision.
  • CEP revisions
  • CEP renewals

 

Life-cycle management of Rest of the world DMF and Dossier:

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

 

US agent and drug listing Services for maintaining the LCM of administrative filings and process:

  • US agent services for filing the updates or coordination with US FDA
  • US Drug Listing services
    • Annual update for Establishment registration (ER)
    • Annual Drug Listing Certification for eDRLS
    • Self-Identification

For Business Query and Discussion

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