Frequently Asked Questions (FAQs)

A Drug Master File (DMF) is a submission of information to the FDA to permit the FDA to review this information in support of a third party’s submission without revealing the information to the third party. NUVO can support in writing and filing the DMF to Global healthauthorities like US FDA, EU, EDQM, WHO, China, Canada, Australia, Rest of world (ROW).

DMFs usually cover the Chemistry, Manufacturing and Controls (CMC) of a component of a drug product e.g. drug substance, excipient, packaging material. Drug product information or non-CMC information may be filed in a DMF. NUVO support is writing, compilation and filing of the DMF with all the CMC data as per ICH (International conference of harmonization)

Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product

Type III Packaging Material

Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation

Type V FDA-Accepted Reference Information

NOBODY, There is no legal or regulatory requirement to file a DMF. Information can be in an Application (NDA or ANDA) OR a DMF.

Maintain confidentiality of proprietary information (e.g., Manufacturing procedure) for the holder and Permit review of information by reviewers at FDA to support applications submitted by one or more applicants

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).

LOA is letter of access which Grants FDA authorization to review the DMF and also Grants the Authorized Party the right to incorporate the information in the DMF by reference. NUVO Consultancy will share the Letter of access format with clients for filing with US FDA

Yes, Type –II DMF is mandatory to be filed in eCTD

Type –III DMF for packaging and Type-IV DMF excipients for now been accepted by US FDA in eCTD. NUVO Consultancy can help you write and make the DMF for your product and convert them in to electronic by eCTD publishing an submit to US FDA.

NUVO Consultancy, can help filing the Annual reports for the drug master file (DMF). These are the submission to keep the DMF active with FDA, by submitting the List of authorized Parties, List of all changes reported since last AR.

NUVO can help you filing the Amendments to the DMF for the changes in the documents, process or any data updating. We can convert them in eCTD and publish the amendment and file with US FDA.

eCTD Dossier or DMF can be submitted Via the ESG – Electronic Submission Gateway to US FDA. NUVO has all the necessary arrangements for submission to FDA. Please contact us.

European DMF is called ASMF, which is active substance master file. Also Europe has a provision for DMF approval in form of CEP/COS from EDQM.

CEP is Certificate of suitability, it is obtained on application of API dossier/DMF to EDQM.

We Do the CEP writing, eCTD publishing and submission of the CEP via CESP portal to EDQM.

Active substance which are official in European Pharmacopeia are eligible for filing of CEP/COS to EDQM, which will undergo the review process and upon successful review and query response and its acceptance, a Certificate of Suitability will be issued for the API. We can support with complete CEP Submission to EDQM from its making to approval.

NOBODY, There is no legal or regulatory requirement to file a DMF. Information can be in an Application (NDA or ANDA) or European marketing authorization (EU-MAA)

Maintain confidentiality of proprietary information (e.g., Manufacturing procedure) for the holder and Permit review of information by reviewers at FDA to support applications submitted by one or more applicants

Not mandatory, although recommended to facilitate communication for foreign company

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).

LOA is letter of access which Grants FDA authorization to review the DMF and also Grants the Authorized Party the right to incorporate the information in the DMF by reference. NUVO Consultancy will share the Letter of access format with clients for filing with US FDA

Yes, Type –II DMF and Active substance master file (ASMF) for Europe is mandatory to be filed in eCTD

Type –III DMF for packaging and Type-IV DMF excipients for now been accepted by US FDA in eCTD. NUVO Consultancy can help you write and make the DMF for your product and convert them in to electronic by eCTD publishing an submit to US FDA.

NUVO Consultancy, can help filing the Annual reports for the drug master file (DMF). These are the submission to keep the DMF active with FDA, by submitting the List of authorized Parties, List of all changes reported since last AR.

NUVO can help you filing the Amendments to the DMF for the changes in the documents, process or any data updating. We can convert them in eCTD and publish the amendment and file with US FDA.

Not mandatory, although recommended to facilitate communication for foreign company

eCTD Dossier or DMF can be submitted Via the ESG – Electronic Submission Gateway to US FDA. NUVO has all the necessary arrangements for submission to FDA. Please contact us.

Agent for DMF purposes NOT the same as agent for Drug Registration and Listing System (DRLS). Agents for DRLS and DMF purposes do not have to be the same. It can be Different. NUVO Consultancy can provide both the services to you. Please contact on info@nuvoconsultancy.com

Yes, it has to be a US representative authorized to perform the drug listing activities.

We at NUVO Consultancy can provide with all the US drug listing services like :

• Establishment registration (ER)
• Labeler code Application
• NDC (national drug code) and Drug listing
• Annual update for Establishment registration (ER)
• Annual Listing Certification for eDRLS
• GDUFA cover Sheet filing
• Self-Identification filing