One of the reasons for the existence of modern legitimate pharmaceutical supply chains is to ensure that these illegitimate drugs are blocked from entry. History has shown that once illegitimate drugs are able to quietly penetrate the protections of the legitimate supply chain it is very hard to find and eliminate them before patients are harmed.
Governments around the world have begun to conclude that the natural protections of supply chains are insufficient to deter increasingly sophisticated criminal attacks, and so some have imposed various forms of serialization, track and trace, and ePedigree regulations.
Meeting these regulations has become an all-consuming exercise for many companies. Here is where Dirk Rodgers Consulting, LLC can help.
Dirk has unmatched experience in the pharmaceutical supply chain, combining years as a warehouse systems technology integrator with a decade focused on meeting the challenge of serialization, track and trace and ePedigree regulations within a large drug wholesaler. Dirk continues to be a leader in the development of the GS1 standards that are necessary in meeting those challenges.
This unique combination of experience has given Dirk unparalleled insight into the problems and the solutions to compliance with these new regulations. Dirk knows the technology and he knows the supply chain business. To help expose the hidden complexities and reveal the often surprising consequences and implications of drug serialization and pedigree laws, Dirk started the RxTrace blog more than three years ago. In RxTrace you can see for yourself how Dirk thinks.
With the passage of the U.S. Federal Drug Supply Chain Security Act as part of the Drug Quality and Security Act (DQSA) in late 2013, Dirk has become the world’s foremost expert on the contents and significance of the regulation. To help companies understand the new law and its many implications he has published “The Drug Supply Chain Security Act Explained”, a section-by-section explanation of the DSCSA.
Solutions that are aimed at meeting these new regulations are primarily made up of technology components, but knowing how these components must work together to accomplish true regulatory compliance as efficiently as possible, that takes true insight. The kind of insight that can only be gained after years of study and action. The kind that can only come from working within the pharmaceutical supply chain. Dirk has that kind of insight.
- Drug, Bio and Device Manufacturers
- Contract Manufacturers
- Contract Packagers
- Retail Pharmacies
- Solution Developers
Contact Dirk today to discuss your needs… and begin to see pharma serialization in a whole new light.