NUVO provides efficient solutions to making good submissions using available data and
Drug master file (DMF) or Active substance master file (ASMF) 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 is not approved nor rejected. It is reviewed in relation to a marketing authorization
application by the sponsor.
NUVO provides efficient technical writing and submission of DMF/ASMF 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:
Type II DMF for US
Applicants (Open) Part
Restricted (Closed) Part
EDMF/ASMF (Applicants and Restricted Part) for EU
Technical Package for API
We provide our professional services but not limited to the following activities:
Review with providing solutions for all the technical documents for API.
Guidance for developing documents and conducting studies as per regulatory
requirements for global market.
Writing and compiling DMF/ASMF as per CTD for US, EU, Australia, Canada, ROW etc…
Submission of DMF/ASMF as per, eCTD, Nees, CTD in PDF or Paper format.
Writing quality overall summary (QOS) as per CTD.
Gap analysis of existing DMF/ASMF.
Query response assistance.
Maintaining life cycle of DMF by preparing and sending its updates, Amendments to
Assistance in query reply to all the agencies and different procedures in EU.
Preparation and submission of variation document in relation to API to assist sponsor for
submitting their variation.
Assistance with various formats and Templates of letters required to be submitted to
agencies like Cover letter, LOA, Debarment certificate, commitment letters etc…
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