An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA’s Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, and route of administration, quality, performance characteristics and intended use.

NUVO assist its clients in preparation and submission of ANDA in eCTD with SPL R4 assistance.

NUVO can undertake but not limited to following activities for ANDA :

ANDA writing, Publishing and Submissions services by NUVO:

  • End to end support for ANDA Dossiers – Module 1 to Module 5
    • 505j
    • 505(b)(1)
    • 505(b)(2)
  • Due diligence
  • Dossier Audit
  • Module 1: Preparation and assistance for finalizing Administrative and prescribing information.
  • Module 2 : Summaries and overviews by expert for Quality
  • Module 3, 4 and 5: Dossier writing for all the three modules (module 3, module 4 and module 5) for generic products as per CTD format.
  • QbR preparation as per guidance.
  • ANDA dossier writing in CTD, publishing in eCTD and Submission by ESG
  • Query response assistance while review of ANDA, NDA or BLA application
  • Assistance in response to request for additional information
  • Support and assistance to overcome refuse to file (RTF)
  • Preparation of structured product labeling (SPL) in R4 eDRLS as per US FDA requirements.
  • Assistance in reply queries and complete lifecycle management activities like Annual updates, Amendments and supplements, Changes to ANDA.
  • Gap Analysis of dossier with suitable solutions to make it approvable.
  • Guidance on Generic drug user fees Act (GDUFA)  (new)
  • Self identification filings with FDA as per GDUFA. (new)
  • Applications for Establishment registrations, labeler code  and drug listing for USA

eCTD Publishing services :

  • eCTD Compilation, QC Review, Technical Validation and Submission Hosting
  • eCTD Lifecycle Management
  • Baseline eCTD : Dossier conversion from Paper/CTD/NeeS to eCTD.
  • Importing and Cloning of Existing eCTD Applications
  • Obtaining pre-assigned DMF number
  • eCTD publishing for Original ANDA for drug product formulation.
  • Any changes to existing Dossier – amendment filing.
    • Change being effective in 0 Days – CBE0
    • Change being effective in 30 Days – CBE30
    • Prior approval supplement – PAS
  • Query response for request for additional information and its publishing.
  • Assistance in OCR (Optical Character Recognition), Embed Fonts, Compliant with Regulatory Requirements
  • Assistance in setting up PDF attributes
  • Assistance in hyperlinking
  • Pdf publishing: PDF – Ready for Submission, Bookmarking, Hyperlinking
  • SPL

ANDA Submission Services:

  • We assist in ANDA submission to US FDA health authorities via its submission portal ESG (Electronic Submission Gateway).
  • All the above mentioned eCTD published ANDA in original, along with amendments, query response can be submitted by us to US FDA.

US agent and drug listing Services:

  • US agent services – Complete support and assistance in co-ordinating and communication with US FDA for the complete filing procedure and its maintainance.
  • US Drug Listing services
    • Establishment registration (ER)
    • Labelor code Application
    • NDC (national drug code) and Drug listing
    • Annual update for ER
    • Annual Listing Certification for eDRLS
    • GDUFA cover Sheet filing
    • Self-Identification

Life-cycle management of ANDA : 

  • Amendments preparations and its eCTD publishing and filing with US FDA
  • Query response to support the amendment filing to safe approval
  • Any changes to existing Dossier – amendment filing.
    • Change being effective in 0 Days – CBE0
    • Change being effective in 30 Days – CBE30
    • Prior approval supplement – PAS

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