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 and dossier writing services for the post approval filings and submissions
- eCTD Publishing services
- DMF & Dossier Submission Services through Submission portals like ESG, CESP
- US agent and drug listing Services for keep the estbalishment registration and drug listing updated annually
- Indian agent services
Life-cycle management EU 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
- Preparation and submission of renewal application for EU.
- Maintaining complete lifecycle of the product.
- Brexit support
- Change in MAH
- Preaparation of ACO
Life-cycle management ANDA’s:
- Assistance in categorizing the changes into the type for US FDA.
- 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
Life-cycle management of Rest of the world DMF and Dossier:
- Changes to the exiting dossier
- Renewal filing and maintaining the same
- Re-registration
- Query responses to the submissions
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.
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
