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Regulatory Affairs | Regulatory Compliance

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

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

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    Regulatory Affairs | Regulatory Compliance Regulatory Affairs | Regulatory Compliance Document Transcript

    • 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, complete ANDA documents, in eCTD format, were may outsource the preparation and compilation of delivered to client for final submission to the FDA. these applications to Clinical Research Organization We met our goal of preparing the ANDA (CROs) of repute. e-application, well within the time framework. We also got a satisfied client since they could make A top-20 pharmaceutical company, wanted to ANDA submissions smoothly and even get it approved electronically submit ANDA to USA FDA, in order to for marketing. We understand our client’s needs from market a generic drug for diabetes in USA. They had a holistic perspective and offer our services predicting performed Bioavailability/Bioequivalence studies and the challenges that lie ahead. This understanding chose MakroCare as functional service provider for made it possible for us to deliver our services in Biostatistics as well as Regulatory Affairs. One of the compliance with the regulatory guidelines. reasons for selecting MakroCare was our experienced team comprising of regulatory strategists, medical About MakroCare writers, biostatisticians and medical, publishing and clinical pharmacology specialists. For conducting the MakroCare, a global clinical services firm, provides statistical analysis of the biostudy, we used fully clinical research support to pharmaceutical, biotechnology, and medical device industries. The validated and industry standard application - SAS and company offers site selection, patient recruitment, the analyzed data were represented in tables as clinical monitoring, quality assurance, medical writing, required by the client. These statistical data tables PMS/Pharmacovigilance, clinical data management, were then converted into eCTD-XML format, using biostatistics and regulatory assistance. third party software, to form eCTD Module 5 (Efficacy section) of the ANDA submission. The remaining MakroCare has offices in USA (New Jersey, Illinois, eCTD modules for ANDA submission - Modules 1 to Pennsylvania, California), India (Hyderabad, New Delhi, 4 were made based on the Administrative, Summary Mumbai, Bengaluru) Europe (Germany-Frankfurt) and and Quality information provided by the client. The Japan (Tokyo). Visit us at: www.makrocare.com Copyright , 2009 by MakroCare. All Rights Reserved. CASE STUDY - REGULATORY AFFAIRS