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Overview on european regulatory affairs and the role of submissions in regulatory affairs

Author:

Damodar Renati and Partha Saradhi Nama, Raghavendra Rao P.V.G. and Yengade Ratnadeep

Subject Area:

Social Sciences and Humanities

Abstract:

Regulatory Affairs is the profession which act as a liaison between the Pharmaceutical Industries and Regulatory Authorities. In this Regulatory Affairs Publishing of submissions to the Regulatory Authority is playing crucial role. In this article, I have done analysis on European Regulatory Agency and the types of submissions used for the publishing of documents and finally the role of eCTD in Submissions. We can conclude that eCTD is becoming mandatory for all the countries in Europe mad also all other countries in future.

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