AMCP dossiers are an essential component of US health plans. They are one of the first and most impactful ways for a pharmaceutical company to demonstrate the medical benefit and economic impact to managed care payers in the United States.
A pharmaceutical company focused on the discovery, development, and commercialization of new treatments for orphan…
The European Marketing Authorization process, for new lifescience products, is harmonized through EMA’s centralized procedure…
US based pharmaceutical companies have lots to consider when tackling the European commercialization path. The…
As mentioned in our first article, the information gathered through due diligence intends to bring…
The EU is the second largest market in the world for pharmaceuticals, which makes it…
On-demand US BLA Regulatory Strategy saved our client time and hiring costs Up against a…
“Leaders who have the experience and skills to deal with teams characterized by diversity are…
Making function decisions in a vacuum. The Challenge A U.S. therapeutic organization that already developed…
