Case Study
Introduction The U.S. client is the manufacturer of IVDs and blood products. The client had created labeling in compliance with the US FDA labeling regulations for a new product. Business Challenge The internal team at the company had conflicting views on whether or...
Africa
Introduction The client is a Fortune 100 company that manufactures a surgical device among other products. Their objective was to launch their surgical device in Russia as soon as possible. Business Challenge The client has a local office in Russia. They still decided...
North America
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) proposed the withdrawal of two generic versions of Johnson & Johnson’s Concerta® marketed by Kremers Urban Pharmaceuticals, a subsidiary of the Lannett Company...
North America
It has been a tumultuous time for many CEOs and executives in America, from Martin Shkreli to John Stumpf and Heather Bresch. Their companies have been involved in high-profile tussles with Congress on issues including drug pricing, R&D costs, aggressive marketing...
Africa
Imagine you are following a controversial political scandal. What would you do? Watch the news unfold on only one channel, or pick up the TV remote and jump between multiple channels? Collecting accurate, reliable and in-depth data is the most crucial goal for...
North America
The FDA’s approval and hence availability of drug products can be expedited through a number of different approaches. An individual or combination of pathways may be suitable to the drug according to its compatibility to the pathway’s criteria.ÂÂ
