The EMA says new import laws and international collaboration means European drugmakers can now rely on the quality of APIs made outside the European Union.
Sponsors are piling on more responsibilities for their CRO partners, but the question of how that will translate into increases in risk and profit sharing is a point of contention.
The parallel QbD (Quality by Design) application review program by the US FDA and EMA is slowly revealing the differences between the two agencies but will never result in identical assessments or outcomes, experts said.
Apparently some folks at DIA weren't discussing 'cloud-based' solutions this year but, as Outsourcing-pharma.com didn't find them, here's the news from those who are adding a little cumulonimbus to their blue-sky thinking.
In a momentous first for both countries, regulatory officials from China and Taiwan sat down at the same table on Tuesday and discussed their relatively similar ideas around the regulation of drug approvals.
Outsourcing-Pharma has come to Boston, US for DIA 2013. Best promotion we've seen so far is Medidata Solutions' tie up with the Michael J. Fox Foundation. Go get a photo with a time machine and Medidata will donate in your name.
Parexel’s growth rate has slowed recently to a pace that the company can more easily keep up with than in years past, CEO Josef von Rickenbach told us at DIA’s annual meeting in Boston on Monday.
Kohlberg Kravis Roberts (KKR) has purchased PRA International for $1.3B, which is about $500M more than previous private equity owner Genstar paid in 2007.