The pharmaceutical industry has seen the rapid growth of biologics, products that are typically temperature sensitive, and need to be refrigerated. This has led to increasing awareness by the regulatory agencies towards distribution practices of most...
DN: In my experience, the single most significant trend in pharmaceutical outsourcing in general, and analytical testing in particular, is the emergence of so-called “preferred vendors”. In the early 1990s there were only a few contract research ...
In order to maintain product quality, safety and efficacy during distribution, Good Distribution Practices (GDPs) specify that temperature-sensitive products are to be distributed (stored, handled and transported) throughout the distribution network ...
Saturday, January 01, 2011
Pharmaceutical companies are increasing their use of outsourcing of manufacturing processes as a strategy for remaining competitive in the global marketplace.
In its short lifetime, the Biologics Outsourcing landscape has already undergone several seismic changes: each upheaval having been driven by changes in technology, financials, and appetite for risk.
For most products, and especially for a successful one, the transfer of analytical methods during development is inevitable.
Sunday, November 01, 2009
The pharmaceutical industry is under tremendous pressure to increase productivity and lower costs while at the same time discover and develop novel therapies.
This article explains the regulatory challenges FDA encounters with current manufacturers’ global outsourcing and the role and responsibilities for those participating in outsourcing.
Today, more and more pharmaceutical companies are outsourcing and offshoring projects which require complexity and demands strict timelines.