Posts in Regulatory Consulting
Resvent chooses bioaccess™ as regulatory and market access consultant to enter the Colombian sleep apnea medical device market

China-based Resvent has chosen bioaccess™ as its regulatory and market access partner to obtain marketing authorization at Colombia's INVIMA towards the commercialization of its sleep apnea iBreeze series of medical devices. bioaccess™ will also search and select a leading distributor for Resvent in Colombia.

Read More
Sight Diagnostics chooses bioaccess™ as regulatory consultant to sell an AI-based diagnostics device for faster blood tests in Colombia

Israel-based Sight Diagnostics has chosen bioaccess™ as its regulatory and market access partner to obtain marketing authorization towards the commercialization of its innovative point-of-care blood diagnostic device, OLO. The OLO device uses artificial intelligence (AI) to optically read small amounts of blood and provide complete blood count tests during a single doctor’s visit. In 2018, Sight Diagnostics received its CE mark and begun selling its OLO device in Europe and other countries.

Read More
LumiThera Chooses bioaccess.™ as its Regulatory and Market Access Consultant to Sell its Innovative Valeda™ Light Delivery System in Colombia

LumiThera, Inc. has chosen bioaccess.™ as its regulatory and market access partner to obtain marketing authorization and commercialize its innovative Valeda™ Light Delivery System in Colombia. Valeda™ is the first approved treatment for dry age-related macular degeneration using photobiomodulation (PBM). LumiThera is at the forefront of the development of  PBM treatments for patients with age-related macular degeneration and other degenerative ocular diseases.

Read More
MMT Appoints bioaccess.™ as Market Access and Regulatory Consultants in Colombia for its AcquiCell® Medical Device

Millenlum Medical Technologies, Inc. ("MMT"), a company specializing in manufacturing and distributing medical devices in liposuction, body shaping, adipose tissue collection and transfer, and autologous cell processing, has selected bioaccess.™ as its market access, regulatory consultant and legal representative in Colombia. bioaccess.™ will help MMT conduct market research, build a distribution network, and obtain marketing authorization for its novel AcquiCell® equipment at Colombia's medical device regulatory agency, INVIMA. 

Read More
Biorius and bioaccess.™ Sign Cooperation Agreement for Cosmetic Regulatory Consulting in Colombia

BIORIUS SPRL ("BIORIUS"), a leading regulatory consulting company in Belgium, and bioaccess.™ , the leading CRO and regulatory consulting company in Colombia, announce a cooperation agreement for Colombia. BIORIUS and bioaccess.™ will work together to help each other clients with their regulatory needs in Colombia and Europe.

Read More