Review Article
Mathew George, Lincy Joseph
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.