Accessing the European Pharma Market: becoming a MAH through dossier adaptation (II)

The European pharma market is becoming more competitive and accessible through its effort to adopt globally acknowledged standards and requirements, it is not surprising the increasing interest of investors to this appealing market. When a non-European company is considering investing in EU business opportunities different strategies may be implemented depending on the company needs. One…

RESIDUAL SOLVENTS IMPURITIES. ICH Q3C

Introduction Solvents used in pharmaceutical industry are generally volatile organic compounds that are involved in many processes of both synthesis and purification of APIs, excipients and medicines. Their use is essential given that, in many cases, they allow to improve yields and selectivities of the processes, facilitate purification stages and even they lead to some…

Accessing the European Pharma Market: becoming a MAH through dossier acquisition.

  Positioned as the second largest pharmaceutical market in the world and showing a steady and extensive growth pattern, Europe’s pharma market is becoming increasingly attractive, but accessing this market implies both regulatory and technical requirements, so different strategies need to be considered to ensure cost-effectiveness. One of the options available for companies seeking to…