NUVO provides efficient solutions to making qualityDrug master file (DMF) submissions. We guide with complete process and documentation required for the safe filing and review of the DMF.
Drug master file (DMF) is the set of series of information for an Active Pharmaceutical Ingredient (API) or Drug substance brought together in CTD format
as per regulatory requirements. DMF provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
Drug master files (DMFs) are submissions to US FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They:
- Allow parties to reference material without disclosing DMF contents to those parties.
- Are not required by statute or regulation.
- Are neither approved nor disapproved. Instead, FDA reviews the technical contents of DMFs in connection with the review of applications that reference them (e.g., NDAs, ANDAs, INDs, BLAs).
NUVO provides efficient technical writing and submission of US DMF for our clients globally.
All documents and data required for the DMF submissions are evaluated and aligned as per the international requirements and guidance. We provide customized service for advice and complete project management for filing of following types of dmf :
- Type II – Drug substance, drug substance intermediate, and materials used in their preparation, or drug product
- Type III – Packaging material
- Type IV – Excipient, colorant, flavor, essence, or material used in their preparation
DMF writing and Submissions services by NUVO:
- DMF Due diligence
- DMF audit
- DMF conversion from Paper/CTD to eCTD
- Module writing for Type –II DMF for Active pharmaceutical ingredient (API), Intermediates and Semi-finished dosage forms.
- Module writing for Type-III DMF for packaging material
- Module writing for Type-IV DMF for excipients,Colorant, Flavor, Essence, or Material Used in Their 543 Preparation
- All modules Viz. Module 1, module 2 and Module 3 writing for all three types of DMF
- Module 2-QOS in QbR format
- DMF writing in CTD, publishing in eCTD and Submission by ESG
- Query response assistance while review when referenced to ANDA, NDA or BLA application
- Assistance in response to request for additional information
- Support and assistance to overcome refuse to file (RTF)
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 DMF for Type –II for API, Intermediate and formulation.
- eCTD publishing for Original DMF for Type –III for Packaging material.
- eCTD publishing for Original DMF for Type –IV for Excipients
- Annual updates for all the DMF
- Any changes to existing DMF – DMF amendment filing.
- Query response for request for additional information
- 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,
DMF Submission Services:
- We assist in DMF submission to US FDA health authorities via its submission portal ESG (Electronic Submission Gateway).
- All the above mentioned eCTD published DMF in original, along with amendments and annual report, query response can be submitted by us to US FDA.
US agent and drug listing Services:
- US agent services
- 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 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.
