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Paolo Biffignandi

What Is a well-established use application and when can it be used?

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

26 Nov 2013 11:47 Regulatory Affairs Blog 1 Comments

Biosimilars sector from EU and US perspectives

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

26 Mar 2013 12:10 Regulatory Affairs Blog

Asia's changing regulatory environment and pharma outsourcing

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

14 Jan 2013 14:45 Regulatory Affairs Blog

Extractables, leachables and QbD

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

20 Nov 2012 17:29 Regulatory Affairs Blog