WCS Processing New FDA Digital Documents, Business As Usual

WCS Processing New FDA Digital Documents, Business As Usual

Questions have arisen about processing the FDA’s digital documentse-CFG’s, e-CPP’s, and others. The convenience and cost-savings are useful to our clients, as the FDA uploads the documents to the pharmaceutical and medical-device companies in digital format, which eliminates significant handling of physical documents.

Once received, clients send the documents to us at WCS, likewise in digital format—and we take it from there. WCS prints the document and prepares it for submission to the U.S. Department of State, essentially the same handling as there was in the old-school days when FDA delivered the documents as physical “hard copies”.

In summary, there is every reason to welcome the new format, with very little change in procedures.Simply receive the documents in digital form, and upload them to WCS Express, our easy-to-use online ordering platform.

Unwrapping the Sweet Surprise: Japanese KitKats Take Center Stage in Our Year-End Adventure

Unwrapping the Sweet Surprise: Japanese KitKats Take Center Stage in Our Year-End Adventure

Who could have imagined that the year-end trip to Japan of our very own go-to techie, Jason, who manages relations with our technology developers, would unveil a world of . . . KitKats. Yes, KitKats.

Already a personal favorite around the office, the familiar blood-orange packaging was a sweet confectionary reminder of childhood—as well as real-time indulgences.

But Jason, our very own bakery detective, returned for the New Year with a special supply of KitKats from the Land of Rising Vending Machines.

No less than baseball, the all-American export has become a staple of Japanese consumption, with a unique look-and-feel consistent with its adoptive home.

KitKats Beyond Borders

One of the reasons behind the popularity of KitKat in Japan is the cultural significance attached to the brand. KitKat is often given as a gift to students before exams, as “Kitto Katsu,” which translates to “You will surely win,” is a popular expression in Japan.

Japanese KitKats come in beautiful decorative packaging, each one a work of art. But what truly sets them apart is the variety of flavors, meticulously researched and developed by expert flavor engineers. Milk Tea flavored KitKats, for your pleasure? Purple sweet potato? Saki? Melon? Peach? Miso Soup? Sweet Red Bean? Coffee Break? And more . . . you’d almost think it was a national obsession! Introduced to Japan in 1973, there are now more than 300 flavors.

A Symphony of Flavors

Jason’s special supply included an assortment of these unique KitKat flavors, and the office was abuzz with excitement. Colleagues gathered around, tasting the exotic treats that had traveled thousands of miles to grace our desks.

As we savored the distinctive flavors, it became clear why Nestlé’s overseas marketing strategy for KitKats in Japan has been a smashing success. The cultural connection, attention to detail, and a flair for innovation have transformed KitKats into more than just a chocolate bar—they are a symbol of Japanese creativity and hospitality.

Expressing Exuberance Through Products

Japan, a powerhouse economy, stands out for its special brand of flamboyance, transforming products into expressions of national exuberance. Many Japanese enterprises, including those who avail our services to authenticate documents in global markets, play a crucial role in global trade. They contribute to a diverse array of consumer goods, advanced medicines, medical devices, and a plethora of goods and services.

All of us at WCSS extend our heartfelt thanks to our Japanese clients for occupying our client portfolio and for their indispensable role in global trade. And a special shout-out to Jason for not only managing our technology relations but also bringing a piece of Japan’s delectable culture into our daily office routine.

So here’s to Nestlé, here’s to Japan, and here’s to the unexpected joy that comes in the form of a KitKat. Because sometimes, a simple chocolate bar can be the bridge that connects us to cultures and flavors beyond our imagination.

 

Regulatory Convergence Logo

WCS Takeaways from RAPS 2015 Regulatory Convergence in Baltimore

This year, I had the good fortune of attending the annual Regulatory Affairs Professionals Society (RAPS) Regulatory Convergence in Baltimore, MD. Being my first Regulatory Convergence, I was excited and unsure of what to expect. As I walked into the massive convention center near the Inner Harbor, I was taken aback by the amount of attendees. I didn’t know where to begin.

This event was truly a convergence, a meeting of the minds, where regulatory professionals with very impressive pedigrees provided interactive sessions covering a host of current regulatory issues.

Having a legal background, I attended the session on “Common Challenges Facing Lawyers in our Globalized Medical Products Industry.” The seasoned attorneys on the panel led an interesting discussion about the necessity of communication between regulatory and legal departments within a company andthe need to anticipate potential issues and addressing them proactively instead of reactively.

I found the session about the Ebola Vaccine Development Response to be fascinating. I felt compelled to sit in on this session, as I live less than a mile from NIH and was watching the helicopter that transported the first Ebola patient to the NIH facilities from my front porch. It was truly amazing to hear how the various agencies came together to execute the approval of the life-saving treatment in such an expedited fashion.

Between the well-executed, informative sessions, the impressive exhibit hall, and the welcoming and friendly nature of the attendees, the 2015 RAPS Convergence did not disappoint. I look forward to attending future RAPS events.

 

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