Mandala International and bioccess.™ Sign Cooperation Agreement for Medical Device Regulatory and Market Access Consulting Services in Brazil, Colombia, and Mexico

Mandala International and bioccess.™ Sign Cooperation Agreement for Medical Device Regulatory and Market Access Consulting Services in Brazil, Colombia, and Mexico.

[ORLANDO, FL, March 5, 2019] - MANDALA International ("MANDALA"), a leading regulatory consulting company in France, and bioaccess.™ announce a cooperation agreement to work together to help each other's clients with their regulatory and market access needs in Brazil, Colombia, and Mexico —the top three medical device markets in Latin America.

For over 12 years, MANDALA has provided regulatory compliance and market access consulting services to the medical device, pharmaceutical, cosmetic, food & supplements, and veterinary industries. Mandala chose to expand its coverage area to Colombia and was looking for a reliable strategic partner to help its clients —especially in the medical device industry— with their regulatory registrations at Colombia's regulatory agency —INVIMA.

Since 2010, bioaccess.™ has provided regulatory compliance consulting services to US and EU medical device manufacturers so that they can cost-effectively obtain regulatory approval at Colombia's INVIMA for their investigational (early-stage clinical trials) and commercial products at Colombia's regulatory agency —INVIMA. In addition, bioaccess.™ also assists its clients with their market access plans and distributor search in Colombia. bioaccess.™ was also looking for a reliable strategic partner to help its clients with their regulatory and market access needs at Brazil's ANVISA and Mexico's COFEPRIS —the countries' regulatory agencies.

Under this cooperation agreement between MANDALA and bioaccess.™, now foreign manufacturers of medical technologies will be able to cost-effectively and timely obtain market clearance for their products, have a well thought out market access plan, and find reliable local distributors so that they can achieve meaningful sales and have long-term growth in Brazil, Colombia, and Mexico —the top three medical device markets in Latin America.

"MANDALA is really pleased to have found a partner with the same quality standards and now be able to help its clients entering the Colombian market with compliant products," said Laurent Hernandez, MANDALA's CEO.

"bioaccess.™ has finally found the perfect match in its search for a strategic partner in Brazil and Mexico. On top of in-depth knowledge of their local markets and regulations, both, bioaccess.™ and MANDALA 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 to have MANDALA as our strategic partner for Brazil and Mexico," said Julio G. Martinez-Clark, bioaccess.™ CEO.

About MANDALA International

MANDALA International (www.mandala-intl.com) offers consulting and operational support for healthcare-related companies seeking to develop their business in Latin America with a special focus on Brazil and Mexico. MANDALA International is the world’s leader for medical device & pharmaceutical regulatory registration in Brazil (ANVISA) and Mexico (COFEPRIS). It is the only service provider authorized to import and distribute drugs in Brazil (Brazilian Registration Holder) and to run an ANVISA-approved laboratory to register pharmaceuticals. MANDALA specializes in the healthcare industry including medical equipment, pharmaceuticals, biotechnology, food supplements, veterinary, cosmetics, and sanitary products.

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

MANDALA International

Laurent Hernandez, ‭+55 (11) 98152-0243‬

Chief Executive Officer

laurent.hernandez@mandala-intl.com