alexa Product Life Cycle Management in Regulated Market of Europe
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
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Review Article

Product Life Cycle Management in Regulated Market of Europe

Mathew George1*, Lincy Joseph2, Shaishav Sandal3 and Santhi Maria Joseph4

1Department of Pharmacology, Pushpagiri College of Pharmacy, Thiruvalla, Kerala, India

2Department of Pharmaceutical Chemistry, Pushpagiri College of Pharmacy, Thiruvalla, Kerala, India

3Department of Pharmaceutical Management and Regulatory Affairs, Jaipur National University, India

4Department of Pharmaceutics, Pushpagiri College of Pharmacy, Thiruvalla, Kerala, India

*Corresponding Author:
Mathew George
Department of Pharmacology, Pushpagiri College of Pharmacy
Thiruvalla, Kerala, India
Tel: +91 8547921687
E-mail: [email protected]

Received date: January 20, 2017; Accepted date: January 21, 2017; Published date: January 28, 2017

Citation: George M, Joseph L, Sandal S and Joseph SM (2017) Product Life Cycle Management in Regulated Market of Europe. Pharm Regul Aff 6:181. doi:10.4172/2167-7689.1000181

Copyright: © 2017 George M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

To study the product life cycle management in the regulated market of Europe Under this title the scope of work is defined as: To study the practical aspects of different phases of life cycle of generic sterilized injectable product in regulated market of Europe, to study the European standards and requirements for registration of injectable drugs, to study the lifecycle start from the product identification by market surveying and till its withdrawal or renewal in the Europe market, the data may contain official information to be taken from the EMEA guidelines, live case studies and live operational projects at International Regulatory affairs department at Claris life sciences Ltd to study, prepare, compile and submit the data according to the CTD format in the regulatory agencies of Europe as critical phase of life cycle. The pharmaceutical industry is now perhaps the most highly regulated of all industries demanding a high level of information to be submitted to governments before a pharmaceutical product is brought to the market place. Each country holds different regulatory department. In this scenario, the product life cycle management in regulated market of Europe upholds a significant value.

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