In terms of difficulty, many would say diagnosing a rare or undiscovered disease is more difficult than finding a needle ...

On June 30, 2017, the FDA published a draft guidance announcing an enforcement delay for the pharmaceutical manufacturer’s requirement under ...

Co-author and contributions by Megan Weldon Over the next few years, global and multinational pharmaceutical companies will need to achieve ...

With a major regulatory deadline approaching this year, pharmaceutical manufacturers across the globe are in varying stages of compliance with ...

Last week, we were fortunate to attend this year’s GPhA Annual Meeting in Orlando, FL. As always, the event offered ...

Many companies have begun implementing serialization solutions and are working towards integration with contract manufacturing organizations (CMOs), 3PLs and trading ...

Together, industry regulations and healthcare reform are impacting how pharmaceutical companies do business. Drug makers are experiencing a heavy financial ...

“We’ll cross that bridge when we get there.” This is the typical approach most of us take on post-production matters ...

As if serialization efforts aren’t complicated enough working within our own manufacturing organizations, syncing our efforts with our trading partners ...

As organizations plan their serialization initiative, I often find that the effort required to validate the complete solution is underestimated.  ...

In my last blog, Piloting Serialization for the Real World, I highlighted that many organizations implementing serialization are very focused ...

With 2015 looming, many pharmaceutical companies are well down the path of serialization. Most of these companies are designing and ...