Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

Regulatory Affairs | Regulatory Compliance


Published on

MakroCare provides global medical device regulatory affairs expertise to streamline submission management and achieve faster product approval.

Published in: Health & Medicine, Business
  • Be the first to comment

  • Be the first to like this

Regulatory Affairs | Regulatory Compliance

  1. 1. 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: Copyright ,2009 by MakroCare. All Rights Reserved.