RJR Consulting, Inc.: Aiding Medical Device Companies in Expanding their Geographic Markets

When it comes to expanding its global influence and market presence, several challenges impede the progress for a medical device company. These can range from lacking an office in the targeted country or insufficient expertise locally in registering a product. Many times, medical device companies do not have the full requirements to enter a country and apply for a product license. If a company doesn’t have the proper local market presence, it becomes impossible for them to register their products. Also, to protect a medical device company's trade secrets and intellectual property rights, it is imperative to carefully select a local consultant to help be in compliance and obtain regulatory approval on all of their submissions.Enter RJR Consulting, a company that can help medical device companies extend their reach and geographical influence, by assisting them in completing the regulatory and compliance requirements necessary to establish their market expansion and get their products to market.

RJR Consulting was established in 2001 as a global regulatory consulting firm for Life Sciences. The company covers more than 95 countries in providing regulatory support to its clients. RJR can be the local Agent / Authorized Representative, when the client has no local office. Over 19 years, the organization was able to gain access to almost every life science commercial market globally for pharmaceuticals, biologics, medical devices, IVDs, and combination products. Its President & CEO, Robert Russell, personally vetted the partners affiliated with the organization, before deciding to work with them. As a result, today, RJR Consulting has over 40 affiliate partners that are highly experienced regulatory firms. These partners have excellent contacts within the global health authorities and are capable of handling a variety of regulatory and compliance-related issues, that are brought forward to them.

For medical device companies that provide their products in the U.S., RJR Consulting handles the submission of 510K’s,PreMarket Approval (PMA’s) and DeNovo applications to FDA. It takes care of similar processes for enterprises that wish to establish their products in ex-U.S. countries. Another vital criterion, required to operate a facility in countries across Europe, Canada, Australia and others. that some medical device manufacturing enterprises may not have is ISO 13485 certification. This GMP certificate ensures a comprehensive quality management system for the design and manufacture of medical devices exists. RJR Consulting helps companies acquire ISO 13485 certification by conducting mock audits of the medical device manufacturing facility before the Certified Body / Health Authority comes and performs the actual inspection.

The clientele of RJR Consulting includes enterprises of all sizes, from small start-ups to Fortune 100 International Medical Device manufacturers. The company provides medical device enterprise services like assisting them in shaping their device product development plans, creating clinical trial applicationsand product registration dossiers including e-submission, justto name a few.

For the future, RJR Consulting is planning to expand its reach and provide regulatory aid to even more emerging markets around the globe. The enterprise regularly looks out for upcoming medical industries that do not have precise regulation and compliance requirements just yet. For example, RJR Consulting is continually observing the developments of cannabis-based products regulatory frameworks and drug delivery systems to fully understand where legislation both in the United States and other countries is headed. As Russell says, “It’s a combination of understanding the movement of the client’s needs, their geographic interests and in helping them stay ahead of the competition.”