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.

About MakroCare

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

Japan (Tokyo).

Visit us at: www.makrocare.comCopyright , 2009 by MakroCare. All Rights Reserved.