News and Insights

Strategic Approaches to Regulatory and Compliance

What You Need to Know about Late-Stage Clinical Trials (Pharma)

The global market for pharmaceuticals continues to grow as manufacturers move to expand their market strategy and product pipeline to new markets and therapeutic areas. Increasing globalization has fueled changes in the regulatory environment, including increased data requirements at the various stages of product development, validation, approval, and production. Additionally,…

Choosing the Right Chief Compliance Officer

Pharmaceutical Compliance Monitor

Finding the right CCO isn’t a simple hiring decision for life sciences companies. They face a range of complex business, regulatory, and market challenges in a dynamic and heavily scrutinized environment. Creating and maintaining a culture of ethics and compliance isn’t about just about the CCO. It’s a decision that…

PDUFA V – A Step in the Right Direction

FierceBiotech

In a Congressional cycle paralyzed by partisan gridlock, early reauthorization of PDUFA — the user fee act for drugs — was hailed as a triumph for the current Congress. Not only did the law pass with bipartisan support, it passed ahead of schedule. So why was this particular piece of…

The Board’s Role in Pharmaceutical Compliance

Pharmaceutical Compliance Monitor

It’s become commonplace to talk about the demanding regulatory and enforcement environment that pharmaceutical companies face. The number and size of recent settlements keep this topic top-of-mind for many. Recent settlements by Johnson & Johnson and Pfizer created significant board oversight requirements, underlining questions about what the role of the…

Post Marketing Safety Surveillance — A Call to Action

Numerof Brief

Exacerbated by recalls and other issues in recent headlines, medical device companies operating on a global basis face an expanding set of legal and regulatory risks and concerns around product safety. Scrutiny from the public and regulators is increasingly focused on ensuring product safety, as demonstrated by FDA funding increases…

Regulatory Affairs – The Shape of Things to Come

The global market for pharmaceuticals and medical devices continues to rapidly evolve, driven in part by significant regulatory changes across regions. Regulatory requirements across markets have a significant impact on matters such as clinical trials and market entry strategies in different regions. In response, companies will need to reevaluate their…