Pharmaceutical Regulatory Affairs: Open Access

Mathew George

Publications

• Review Article
  Product Life Cycle Management in Regulated Market of Europe
  Author(s): Mathew George, Lincy Joseph, Shaishav Sandal and Santhi Maria JosephMathew George, Lincy Joseph, Shaishav Sandal and Santhi Maria Joseph
  
  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 .. Read More»
  DOI: 10.4172/2167-7689.1000181

  Abstract PDF