C A S E S T U D Y
R E G U L A T O R Y A F F A I R S
CASE STUDY - REGULATORY AFFAIRS
Practical Knowledge of Regulatory Guidelines for E-Drug
Marketing Applications Makes for Smooth Submissions.
One of our clients wanted to submit electronic Abbreviated New Drug Application (ANDA) to
USA FDA, to get market approval for a generic drug. We prepared the entire ANDA in
electronic Common Technical Document (eCTD) XML format.
Several pharmaceutical companies, mainly in USA
and Europe, make submissions to the drug regulatory
agency (for clinical trials approval and drug marketing
authorization) in electronic format. Electronic
submissions ensure faster processing and approval of
the marketing applications. In USA, it is mandatory
that eCTD format is used for electronic submissions of
IND, NDA, ANDA and BLA regulatory applications.
Pharmaceutical companies, who want to make
electronic submissions but don’t have the regulatory
and technical know-how or have resource constraints,
may outsource the preparation and compilation of
these applications to Clinical Research Organization
(CROs) of repute.
A top-20 pharmaceutical company, wanted to
electronically submit ANDA to USA FDA, in order to
market a generic drug for diabetes in USA. They had
performed Bioavailability/Bioequivalence studies and
chose MakroCare as functional service provider for
Biostatistics as well as Regulatory Affairs. One of the
reasons for selecting MakroCare was our experienced
team comprising of regulatory strategists, medical
writers, biostatisticians and medical, publishing and
clinical pharmacology specialists. For conducting the
statistical analysis of the biostudy, we used fully
validated and industry standard application - SAS and
the analyzed data were represented in tables as
required by the client. These statistical data tables
were then converted into eCTD-XML format, using
third party software, to form eCTD Module 5 (Efficacy
section) of the ANDA submission. The remaining
eCTD modules for ANDA submission - Modules 1 to
4 were made based on the Administrative, Summary
and Quality information provided by the client. The
complete ANDA documents, in eCTD format, were
delivered to client for final submission to the FDA.
We met our goal of preparing the ANDA
e-application, well within the time framework. We
also got a satisfied client since they could make
ANDA submissions smoothly and even get it approved
for marketing. We understand our client’s needs from
a holistic perspective and offer our services predicting
the challenges that lie ahead. This understanding
made it possible for us to deliver our services in
compliance with the regulatory guidelines.
MakroCare, a global clinical services firm, provides
clinical research support to pharmaceutical,
biotechnology, and medical device industries. The
company offers site selection, patient recruitment,
clinical monitoring, quality assurance, medical writing,
PMS/Pharmacovigilance, clinical data management,
biostatistics and regulatory assistance.
MakroCare has offices in USA (New Jersey, Illinois,
Pennsylvania, California), India (Hyderabad, New Delhi,
Mumbai, Bengaluru) Europe (Germany-Frankfurt) and
Visit us at: www.makrocare.com
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