Similar to Changes Being Effected (CBE). A filing with the FDA to gain approval of a moderate change, i.e., a change that has a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as… Read More »
A filing with the FDA to gain approval of a major change that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of… Read More »
Dennis Gillings, CBE, chairman and chief executive officer of Quintiles Transnational Corp., dedicated a new facility in Overland Park, KS, with Secretary David Kerr of the Kansas Department of Commerce.
The 236,000-sq.-ft. building will house Qu… Read More »
Quintiles Transnational Corp. will build a new structure in Overland Park, KS to house the Clinical Development Services (CDS) and Clinical Pharmacology units now in Kansas City and the Phase I Research unit located in Lenexa, KS. The new facility wi… Read More »