Clinical Research Solutions
The Importance of Compliance in Prescription Drug Advertising Amid Cuts to the Office of Prescription Drug Promotion The Office of Prescription Drug Promotion (OPDP), a key Office of the U.S. Food...
Clinical Research Solutions
In part one, we covered the regulatory framework, compliance, and Wholesale Distribution Authorization. In part two, we’ll explore how success in Europe goes beyond regulatory approval—it’s also...
Clinical Research Solutions
Ensuring patient safety and compliance with pharmacovigilance (PV) regulations is a critical responsibility for marketing authorization holders (MAHs). For companies planning to market their...
Clinical Research Solutions
According to the European Federation of Pharmaceutical Industries and Associations, Europe is the second-largest pharmaceutical market in the world. Therefore, it is not surprising that many biotech...
Clinical Research Solutions
Understanding Health Technology Assessment (HTA) authorities’ requirements throughout the product development phase is crucial for a successful market access strategy and planning. This will increase...
Clinical Research Solutions
The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy causing many global organizations to investigate the consequences of the tariffs on their...
Clinical Research Solutions
The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy. Significant changes have been announced causing many global organizations to investigate...
Clinical Research Solutions
In the highly regulated world of pharmaceuticals, medical information (MI) services play a critical role in ensuring that healthcare professionals, patients, and the public have access to accurate...