dmfpharmadossiers.pptx

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Manufacturers, Excipient Manufacturers, Pharma
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Export Their Products To Various Countries Around
The World. We Are Doing Very Well Since Last Past 8
Years In The Field Of Pharma Regulatory
Documentation.

A Drug Master File (DMF) is a type of submission made
to the Food and Drug Administration (FDA) to provide
important information related to facilities, processes or
ingredients used for manufacturing, packaging or
storing of any human drugs. Though it is not
mandatory to file a DMF, the submission is subject to
the discretion of the manufacturer. DMFs are generally
filed to support an Investigational New Drug
Application (IND), a New Drug Application (NDA), an
Abbreviated New Drug Application (ANDA), any other
DMF, application of export, or to support any of these.

TYPES OF DRUG MASTER FILES
There are five types of DMF's:
 Type I Manufacturing Site, Facilities, Operating Procedures, and
Personnel.
 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.
Each DMF should contain only one type of information and all supporting data. See Section IV.C
of the guideline for more detailed descriptions of the kind of information desired in each type.
Supporting information and data in a DMF can be cross referenced to any other DMF.

DMF WRITING AND SUBMISSIONS SERVICES:
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 SERVICES:
Open part DMF
Closed part DMF
File a new DMF, MAF, or VMF
Update or Amend an MF
Convert a paper DMF to Ectd
DMF creation
DMF Submissions
DMF AnnualReports

DMF Amendments
DMF Authorization letters
DMF Closure Requests
DMF Transfer Requests.
We assist in DMF submission to US FDA health
authorities via its submission portal ESG (Electronic
Submission Gateway).

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.

US agent and drug listing Services:
US agent services
US Drug Listing services
Establishment registration (ER)
Label or code Application
NDC (national drug code) and Drug listing
Annual update for ER
Annual Listing Certification for eDRLS
GDUFA cover Sheet filing
Self-Identification

DMFs submitted to the FDA must be in English. In case, it is in
another language, a certified English translation must be
included in the submission. A DMF must contain the
following information:
1. Transmittal Letters
a. Original Submissions – Includes original submission
identification, application identification, authorized
representative’s signature and signer’s title with typewritten
name.
b. Amendments – Includes amendments to the original
submission identification, purpose of submission, authorized
representative’s signature and signer’s title with typewritten
name.

2. Administrative Information
a. Original Submissions – Includes name and addresses of
DMF holder, corporate headquarters, manufacturing facility,
agents etc., responsibilities of all the personnel involved in
the manufacturing process, statement of commitment.
b. Amendments – Name of the DMF authorized person along
with the address of correspondence, DMF number, page
number of sections affected by the amendments, name and
address of each responsible person of respective IND, NDA,
ANDA, DMF, or Export Application along with the number of
all the applications etc.

Authorization for Journey of Product from the Laboratory to
Pharmacy Shop (Discovery to Market)
Huge investments and high stake in commercialization of new
pharmaceutical product.
“Right First Time” approach is necessary as time taken for the
product to reach market is critical for success
Foremost point of contact between the company and regulatory
authorities.
Coordination of scientific endeavors with regulatory demands
throughout life of the product.
Helps company meet all regulations and guidelines thus
maximizes profits.

DMF compilation in CTD Format / Country Specific format.
Open & close part DMF writing.
Review of DMF For Submission.
Type II (Active Ingredient) DMF Preparation and submission to US
FDA.
European Certificate of Suitability (CEP) submission and
Preparation.
Canada Submission & Preparation.
We can also help you with Analytical Testing – Elemental Analysis,
Validations, Stability, etc.
Well Qualified Team.

Professional
Experience
Thinking "outside the box“
Interpretation of Regulations
Knowledge Transfer
Cost Effective
Space Saving
Time Saving
Continuity of work

We help our clients, For product registration at MoH,
Solving all MoH queries & providing 100% authentic and
quality data.
All information contained in a Drug Master File is
considered confidential to the holder. Neither the FDA
nor other outside party may have access to or release the
file without the holder's consent. We enable multiple
users with an intuitive user-friendly interface and
enhances cost and time effectiveness. We commit to
being a good corporate citizen and proves a leverage in
the Pharmaceutical and Life sciences businesses.

Membership
Individual
Candidate
Pharmaceutical
Company
Benefits of
association

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