NUVO Consultancy provides efficient solutions to making quality Drug master file (DMF) submissions for entire Globe like US FDA, EU but not limited to them. We offer services for DMF in common technical format (CTD) as per ICH for WHO, China, Japan and rest of the world market. We guide with complete process and documentation required for the safe filing and review of the DMF. We have cloud bases process and system to operate across the globe and round the clock.
Following are the activities and services provided by NUVO in brief:
CTD DMF module writing and Submissions services by NUVO:
- DMF Due diligence
- DMF audit
- DMF conversion from Paper/CTD to eCTD
- Module writing for Applicants part (AP)&Restricted part (RP) of DMF for Active pharmaceutical ingredient (API), Intermediates and Semi-finished dosage forms.
- All CTD modules Viz. Module 1, 2 and 3 writing for DMF
- DMF in CTD/NeeS/eCTD
- Query response assistance while review when referenced to dossier application
- Prequalification of API assistance for WHO
- Preparation of DMF as per individual country requirements like China, Japan etc.
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
- eCTD publishing for Original DMF for API, Intermediate and formulation.
- Any changes to existing DMF or its revision 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 health authorities via its submission portal or through cloud secure link.
- All the above mentioned eCTD published DMF in original, along with changes and query response can be submitted by us to Health Authority.
Life-cycle management of Drug Master File (DMF) :
- DMF revisions preparations, eCTD publishing and filing with respective health authority
- Query response to support the amendment filing to safe approval
- DMF updating and its complete revision/renewals.
For more details and understanding on DMF read below:
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.
DMF are submissions to European regulatory agencies across Europe in all individual countries used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMF is never approved nor disapproved, but is reviewed every time it is referenced in the dossier application of drug product.
DMF constitutes of two parts, Applicants Part (AP) /Open Part (OP) and Restricted Part (RP)/Closed Part (CP).
Applicant’s part /Open Part has the information on chemistry manufacturing and control (CMC) information of API included in it for the customer reference for its inclusion in its Marketing Authorization Application (MAA) Dossier for drug product formulation. Which is further submitted to various Health authorities across the globe.
Restricted Part / Closed Partalsohas the information on chemistry manufacturing and control (CMC) information of API included in it for the regulatory health authority reference for its evaluation against the Dossier submitted in formulation (drug product) application to various Health authorities across the globe.
They:
- Allow parties to reference material without disclosing restricted part or close part of DMF contents to those parties.
- Are not required by statute or regulation.
- Are neither approved nor disapproved. Instead, regulatory health authorities reviews the technical contents of DMF in connection with the review of Drug product dossier application that reference them
NUVO provides efficient technical writing and submission of 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.
Please contact info@nuvoconsultancy.com with all DMF related submission services.
