CIO Bulletin

Globizz Consulting — Simplifying US regulations for expanding business and providing consulting services from a business perspective

More than 328 million individuals make up the US market, which accounts for nearly one-fourth of global GDP. Any company's growth may transform when it achieves success in the US.

However, companies looking to join the U.S. market are frequently confronted with extreme difficulties. In order to even be given the chance to establish themselves in the country, entrants must adhere to complex regulatory compliances in key sectors like insurance, healthcare, money management, retail banking, and telecommunications. The complexity may be overt, as in the case of complex charge structures used by retail banks or lengthy service agreements filled with confusing legalese. However, complexity is frequently implicit and unexplained; for instance, patterns in an expert’s service delivery quality or an insurance company’s payment practices.

It is sometimes possible to outperform rival companies in the fiercely competitive US market by selecting the correct partner or consulting firm to help you navigate the market's complexity. Since 2005, Globizz Consulting is one such company that has been offering regulatory consulting services to foreign companies having issues with regulatory compliance in the U.S.

Recently, CIO Bulletin spoke exclusively to Takahiro “Harry” Haruyama, the Founder and President of Globizz Consulting. The following excerpts are taken from the conversation that ensued

Q. What was the inspiration behind the founding of Globizz Consulting?

Globizz is a business and regulatory advisor to foreign companies that wish to expand their business in the U.S.

Specifically, we consult for companies in the healthcare, medical device, food, drug, and cosmetic industries. We had observed a vast number of international companies that had come to the U.S. in hopes of developing their companies here but had failed to see any growth due to a limited understanding of U.S. culture and business climate. Although these businesses had great potential since their products could be highly beneficial to U.S. consumers, they were still unable to find success. We decided to found Globizz in order to find innovative solutions to these types of issues and help bring these exciting products to the American public. In addition to U.S. business expansion consulting, we also offer FDA consulting and submission assistance, market research support, EPA, USDA, and California Prop 65 advising services. We continue to find inspiration from our international clients, who bring products from around the globe that help improve the health and wellbeing of U.S. citizens.

Q. Why did you find it necessary to start a consulting firm specializing in U.S. regulatory services?

As previously mentioned, Globizz’s client base is comprised of non-US accounts that want to enter the U.S. market. Regulation systems vary by country, so overseas expansion can be a big challenge for foreign companies to overcome in a timely and effective manner.

Over the years, we have witnessed many medical device firms from other countries incorrectly assume that FDA regulations are similar to those of their home countries. Unfortunately, this assumption often leads to inadequately prepared documents that fail to meet FDA requirements.

Based on our experience, a foreign business’ chance at success is more dependent on their pre-market activities than their post-market activities since these companies tend to fail before making their first sale. Precious money and time can be wasted by foreign businesses who are unaware of the registration processes and are blindsided by unexpected tasks requested by the Agency. Through nearly 20 years of experience in the field, we have gained immense knowledge about the differences in regulations and business cultures between different countries and are able to offer sage advice to help businesses overcome these regulatory hurdles.

Q. What distinguishes Globizz Consulting from other U.S. Regulatory consulting firms? What is the USP (Unique Selling Proposition) of Globizz in comparison to its competitors?

Globizz offers a unique approach to regulatory compliance matters because we prioritize diversity on our team. Each of our team members has varied backgrounds and perspectives, and they come together to offer our clients multiple pathways towards success. We believe that each request presented to us requires personalized solutions that can only be found by examining the task from several different angles. For our medical device clients, we provide team members with backgrounds in fields such as marketing, engineering, and medical practice. By diversifying our team, we are able to broaden the advice we offer to our clients to go beyond regulatory assistance and include other parts of expansion efforts, such as general business consulting.

While our competitors are solely focused on FDA regulation clearance, Globizz is looking at the big-picture business goals of our clients: profitable business. Our team is committed to delivering regulatory results and going one step further to explore how we can enhance the value of our clients’ products in the US.

Q. What are your goals for the company in the next 5 years?

Globizz has very exciting goals to greatly expand the geographic areas where we offer our services. Originally, the majority of our clients were based in Japan; however, we have slowly expanded our client base to include companies across Asia and Europe as well. In the next five years, we hope to further expand our services to cover more territories. We will become a U.S. business and regulatory expert for companies from many countries. Ultimately, our goal is to share the business incubation strategies and infrastructure insights that we have gained from our experience with foreign entrepreneurs making U.S. additions to their businesses. As a result, we can help deliver great products from across the world to the U.S.

Additionally, Globizz plans to continue developing the list of services we offer. One recent focus of ours has been to help medical device manufacturers grow their network in the U.S. We work hard to match and connect medical device manufacturers, distributors, and other companies or organizations. Globizz plays a mediatory role for several different types of market players, big and small, which allows us to help diversify the networks we create.

Our ultimate mission is to ensure that businesses are able to begin their U.S. journey with a system tailored to their needs and goals. We understand that each company is unique and requires a different U.S. market entry strategy. Specifically, we have found that there are so many highly innovative but small companies in the world that hold so much potential. We want to help secure the right place in the market for them. In the next half decade, Globizz wants to give everyone an equal chance to enter the dynamic U.S. market.

Making compliance hassle-free for international firms who wish to break into the U.S. market

The Founder and President of Globizz Consulting, Takahiro “Harry” Haruyama, encourages innovation and creativity within his company because he believes that both values are essential for finding solutions to the unique challenges that arise in the field of regulatory consulting.

Harry holds a wealth of knowledge from his over 18 years in the industry across multiple countries. He is often invited to speak as an FDA regulatory consulting expert at public and private events. He has also been assigned as a coordinator for the Japanese Ministry of Economy, Trade, and Industry (JETRO).