[ORLANDO, FL, June 2, 2020] - Emergo by UL ("Emergo"), a global medical device and healthcare technology consultancy, and bioaccess™, a medical device contract research organization, and market access consultancy focused in Latin America, have announced an agreement to help each other's clients with their clinical research, regulatory compliance and market access needs in Brazil, Colombia, Costa Rica, Mexico, and Peru — some of the most attractive medical device markets in Latin America.

 Since 1997, Emergo has provided value-added regulatory and market access services to medical device manufacturers worldwide. Device manufacturers continue to expand into new markets, chasing growth driven by aging populations in markets such as Japan and Europe, and growing wealth in emerging markets such as China and Brazil. These trends, combined with continually evolving regulatory requirements, are driving continued demand for regulatory and market access services. Many small- to mid-size manufacturers lack the resources and expertise to navigate complex regulatory and market access issues.

Clinical trials have increased in all geographic regions and development categories. A Harvard Global Health Institute paper shows that growth has been highest in Asia and Latin America and among low- and lower-middle-income countries with emerging economies. The paper concludes that US companies are increasingly outsourcing clinical research to developing countries.

 Latin America has seen significant growth in medical clinical trials. ClinicalTrials.gov data reveals that from 2000 to 2010, there were 255 medical device clinical trials in Latin America; there were 891 from 2011 to 2017 — an impressive 249 percent growth. Moving clinical studies, estimated to account for 40% of drug development costs, to an emerging country may reduce study expenses by 60%. Clinical researchers, including CROs, are increasingly using global networks to reduce costs and accelerate recruitment.

 Emergo provides strategic clinical consulting support for clients that need to conduct pre- and post-market clinical studies for medical devices. Since 2010, bioaccess™ has helped medical device manufacturers do their early-stage clinical studies in Latin America, with a particular focus on Colombia. The agreement between bioaccess™ and Emergo will help them direct clients to the services they need in Latin America or elsewhere.

 Since 2010, bioaccess™ has provided regulatory compliance consulting services to US and EU medical device manufacturers. bioaccess™ allows companies to cost-effectively obtain regulatory approval from Colombia's INVIMA for their investigational (early-stage clinical trials) and commercial products. Also, bioaccess™ assists its clients with their market access plans and distributor searches in Colombia. bioaccess™ was looking for a reliable service provider to help its clients with their regulatory and market access needs at Brazil's ANVISA, Mexico's COFEPRIS, Peru's DIGEMID, Costa Rica's Ministry of Health, and has chosen Emergo to fill this role.

Using the services of Emergo and bioaccess™, foreign manufacturers of medical technologies can more cost-effectively conduct clinical trials in Colombia, obtain market clearance for their products in a more timely manner, and improve overall market access in the Latin America region.

 “We are pleased to enter into this relationship with bioaccess™ and are now able to offer our clients an affordable option to conduct high-quality clinical research, said Michael van der Woude, General Manager, Emergo by UL.

"bioaccess™ has finally found the perfect match in its search for a strategic partner in Brazil, Costa Rica, Mexico, and Peru. On top of in-depth knowledge of their local markets and regulations, both bioaccess™ and Emergo share a commitment to reliability, cost-efficiency, speed, and client success mentality—this is key for foreign companies looking to achieve long-term growth in Latin America. I am thrilled that Emergo is ready to help our mutual clients in Latin America," said Julio G. Martinez-Clark, bioaccess™ CEO. 

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About EMERGO by UL

EMERGO by UL is a leading regulatory consulting firm specializing in global medical devices and IVD compliance. Its comprehensive solutions are designed to help clients achieve and maintain regulatory and commercial success. With a presence on six continents, Emergo provides real-time service and on-the-ground expertise. Learn more about how Emergo can help you grow at EMERGObyUL.com.

About bioaccess™

bioaccess™ (www.bioaccessla.com/) is a US-based contract research organization (CRO), regulatory, and market access consulting company that delivers a full spectrum of offerings from bench to commercialization so that foreign medical device companies can have long-term success in Colombia and the rest of Latin America.

Media contact

bioaccess™

Julio G. Martinez-Clark, +1 (954) 903-7210

Chief Executive Officer

jmclark@bioaccessla.com

EMERGO by UL

Stewart Eisenhart, +1 (202) 530-6165

Manager, Copy/Editorial

stewart.eisenhart@ul.com