White Papers related to Regulatory Affairs and CMC
White Paper
Growing regulatory complexity and mounting cost pressures mean that biopharmaceutical companies can struggle to sustain post-launch product revenue streams in today’s hyper-competitive global markets. More than ever, organizations are looking to strategically outsource the regulatory lifecycle management of their established products to help manage compliance risk and reduce costs, freeing up key internal personnel to focus on strategic projects.
White Paper
Globalization has broadened opportunities for companies to make their products available to more people in more markets, while at the same time ensuring patients in emerging markets have access to products that can change or even save lives.
White Paper
Download our recent whitepaper to gain deep insights into EU Clinical Trial Regulation.
White Paper
This paper gives details on the background and recommended steps about the Analysis of EMA’s Product Management Services, the current Implementation Guide and future Development.
White Paper
This paper highlights just a few key points that need consideration ahead of achieving and maintaining CMC Compliance in a more sustainable way.