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
