In the News

This Week’s Top Headlines FDA, EU Release New Pharmaceutical Regulation Agreements Posted 3/08/17 Earlier this month, the US FDA and multiple EU drug inspection agencies released amendments to the Pharmaceutical Annex of the 1998 U.S.-EU Mutual Recognition...

Key Differences and Similarities between the ACA and AHCA

The GOP’s Health Care Plan to Replace Obamacare On March 6, the Republican Party released its legislative plan to repeal and replace the Affordable Care Act, more commonly referred to as Obamacare. The GOP explained the purpose of the bill stating, “We’re delivering...

Harmonizing Medical Device Package Labeling Across Markets

Harmonizing Medical Device Package Labeling Across Markets Common Symbols and What They Mean A picture is worth a thousand words. This is especially true in the Medical Device Packaging and Labeling industry. Symbols are an important tool to harmonize medical device...

What’s Next?

How the FDA Data Integrity Draft Guidance is Affecting the Pharmaceutical Industry Data integrity, as part of an automated production system, is an important factor for the success of a pharmaceutical.  Inconsistencies in data compliance can deny vital information...

Building the Pre-Launch Road-Map

Building the Pre-Launch Road-Map Expert Tips for Navigating the Pre-Launch Phase Expert Tips for Navigating the Pre-Launch Phase       Evolving complexities and increased scrutiny of the pharmaceutical industry have dictated a heavy reliance on early...