EARLY-STAGE/FIRST-IN-MAN/FIRST-IN-HUMAN/PILOT MEDICAL DEVICE CLINICAL TRIALS
MARKETING AUTHORIZATION/REGULATORY REGISTRATION/INVIMA
MARKET RESEARCH/MARKET ACCESS/ENTRY STRATEGY
"This decision to engage bioaccess.™ was made to increase our focus and visibility within South America. It is of the utmost importance that we partner with distributors that have influence and a good track record within the Colombian market."
“Traditional clinical trials in the U.S. can take years and millions — or even billions — of dollars. We believe we have the scientist, the technology, the physicians, and the lab partners that are necessary to get this trial done faster in Colombia [with bioaccess.™].”
“Preparation for the Colombia trial entailed an enormous amount of time and effort, and it is a credit to our internal team and the folks at bioacess.™, who worked together seamlessly to meet our tight submission schedule.”
— Robert Bergman, CEO, Hancock Jaffe Laboratories, Inc.
Imagine if you could conduct clinical research and sell your medical device in a multi-billion market with a 50-million population with universal healthcare.
With a 30-day regulatory MoH approval for medical device trials.
With OECD membership that ensure alignment of its legislation, policies and practices to global first-world standards.
With a free-trade agreement with the US, the EU, and the Pacific Alliance (a developing single economic and regulatory market for Mexico, Peru, Chile, and Colombia).
With a fast and efficient regulatory pathway —acceptance of USA, EU, Canada, Japan, and Australia free-sale certificates.
Foreign medical device design and development companies struggle to find a cost-effective clinical trial site or to gain market share in Colombia —and the rest of Latin America. They are unfamiliar with the region and lack in-house experts who can operationalize a successful clinical research, market access, or regulatory strategy.
bioaccess.™ brings Colombia —and Latin America— closer to you. We provide you with clinical research, market access, and regulatory offerings so that you can achieve long-term growth in Colombia and the rest of Latin America.
bioaccess.™ has a regulatory team based in Colombia and includes members with over 20 years of proven experience. They have processed and approved hundreds of regulatory dossier files for clinical trials and product registrations.
Julio is a savvy leader with an indelible reputation for delivering inventive and growth-focused business strategies. Julio is recognized for his entrepreneurial spirit, grit and vision that build the foundation for successful ventures. Julio worked for Lucent and Nortel —large global telecom companies— and was the co-founder and president of a real estate investment firm in Orlando, FL, among other ventures. Julio has been working with US medical device companies for over 10 years helping them design and implement successful clinical trial, regulatory and market entry/access winning strategies. Julio has a bachelor's degree in electronics engineering and a master's degree in business administration (MBA). Julio is a recognized medical device expert and his insights on the medical device industry have been featured on industry-leading publications such as Med Device Online and Clinical Leader. Julio is based in Orlando, FL. Julio is based in Orlando, FL.
Monica leads the company's operations, logistics, accounting, human resources and general corporate and project-related administrative matters. Monica has worked for global companies such as Alcatel-Lucent and Toshiba. She has a B.S. degree in computer sciences and graduate studies in business management. Since 2013, Monica has been involved with a myriad of medical device companies to operationalize their regulatory and market access/entry strategies. Monica is based in Orlando, FL.
Osvaldo leads our company's business development activities by promoting Colombia's clinical research and market access opportunities to medical device manufacturers looking to do business in Latin America. Osvaldo has worked with hundreds of life science companies to help them formulate their market entry and clinical trial strategy in Colombia. He has a double B.S. degree in international business and political sciences. Osvaldo is based in Barranquilla, Colombia.
Ana G. Criado, Director of Regulatory Affairs
Ana is our regulatory affairs expert and leader. She worked at Colombia’s regulatory agency —INVIMA— for over 20 years in different executive and leadership roles. She is a biomedical engineering university professor at Universidad Javeriana and Universidad de los Andes; two of the top private universities in Colombia. Ana is an external regulatory consultant for the Colombian operations of global companies such as General Electric, Omron Healthcare, Mindray, and others. She has a degree in chemical pharmacology; a master's degree in health economics & pharmaeconomics; and certificate degrees in clinical epidemiology, good clinical practices & study monitoring, and pharmacovigilance. Ana is also the founder and CEO of Mahu Pharma; a Colombian company with licenses to cultivate cannabis for medicinal and scientific use and for the manufacturing of raw materials for cannabis-based products.Ana is based in Bogota, D.C., Colombia.
Cris is our lead clinical research and epidemiology expert. She has a microbiology degree from Javeriana University —one of the top universities in Colombia and in Latin America; she worked for Quintiles —the leading CRO in the world; she has a master’s degree on epidemiology from Universidad del Norte —the leading university in Colombia’s Caribbean coast. She was also the research director at COFCA —one of the leading ophthalmology research centers in Colombia. Cris has worked in a number of study protocols that have been approved for trials and have successfully managed these trials. Cris is based in Barranquilla, Colombia.
Yasmin S. Hernandez, Senior Regulatory Associate
For over 20 years, Yasmin has been involved in clinical research in different roles. She has been directly involved in clinical trial IRB/EC and INVIMA regulatory submissions, adverse event reporting, trial start-up and closures, logistics and inventory management of investigational products, etc. From 2006 to 2014, Yasmin worked for Sanofi —one of the top 10 global pharmaceutical companies— as clinical trial regulatory affairs and investigational product coordinator, and from 2014 to 2018 she worked for PRA Health Sciences —one of the top 10 global CROs— as regulatory affairs specialists. Yasmin is based in Bogota, D.C., Colombia.