The legal basis of the application has a profound impact on the extent and nature of the data provided in the dossier and it is therefore of critical regulatory importance. more »
Nov 26, 2013
by Paolo Biffignandi
in Regulatory Affairs Blog
Biosimilar medicines, one of the fastest growing sectors of the industry, constitute a major share of pharmaceutical expenditure in the EU, the US and globally. From a regulatory perspective, they are a new paradigm in drug development, similarly... more »
Mar 26, 2013
by Paolo Biffignandi
in Regulatory Affairs Blog
Asia is the fastest growing pharmaceutical market in the world, providing significant opportunities for drug development and marketing. Consequently, pharmaceutical regulations in this region are fast gaining attention... more »
Jan 14, 2013
by Paolo Biffignandi
in Regulatory Affairs Blog
Extractables and leachables are increasingly becoming a cause of major concern for both the pharmaceutical industry and regulatory bodies. The development of unique packaging, novel formulations and drug-coated medical devices has exacerbated... more »
Nov 20, 2012
by Paolo Biffignandi
in Regulatory Affairs Blog
