We deliver a full spectrum of clinical research, market access, and regulatory consulting services from bench to commercialization in Colombia and the rest of Latin America.
Gerardo V. Noriega
Director of Product Development
Gerardo is a medical technology development expert. He is an entrepreneur and innovator; he founded three medical devices companies and has been a consultant to over 50 Medtech companies in the Silicon Valley area. He is an associate professor of bioengineering and a member of the board at Santa Clara University (School of Bioengineering and Bannan School of Engineering) in the San Francisco Bay area. Gerardo is also a member of the University of San Francisco's Surgical Consortium, and a BMES Executive Committee Founding Member at the Simon Fraser School of Bioengineering Innovation Boulevard EiR. BC, Canada. Gerardo holds a B.S. degree in industrial and systems engineering from San Jose State University and a master's degree in bioengineering and biomedical engineering from Simon Fraser University. Read more.
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.
Director of Clinical Research
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.
Antonio J. Trujillo, PhD
Director of Market Research and Access Projects
Dr. Trujillo, is currently an associate professor, at the Health Systems Program, Department of International Health, Johns Hopkins Bloomberg School of Public Health. He is an economist from the Catholic University in Caracas, Venezuela, holds a Masters in Public Policy from Columbia University in New York, and a PhD from the University of North Carolina, Chapel Hill. Dr. Trujillo has been a consultant for the Inter-American Development Bank, and the World Bank, and several life science companies. Dr. Trujillo has has won significant honors, awards, and research grants, has published 48 peer-reviewed journals articles, seven book chapters and reports, and has been an international speaker in over 35 events. Dr. Trujillo is the director of the Master of Health Science (MHS) in Health Economics degree program at Johns Hopkins Bloomberg School of Public Health. He teaches an advanced econometrics course on program impact evaluation using observational data and a course on behavioral economics and public health. Read more.
Advisor; Clinical, Regulatory & Quality
Armin is an entrepreneurial medical device executive with a broad, multi-disciplinary background. His extensive work with start-up companies has resulted in many successful worldwide product launches. His broad medical device background includes implantable devices, disposables, diagnostic and biotech products. He is a leader and builder of R&D, quality/regulatory/clinical affairs & operations structures within organizations. Armin is the CEO of SunTrix Medical; a clinical, regulatory and quality medical device consulting company. He is also the co-founder and chief operations officer of VasoFlow Medical; a medical device company focusing on innovative products for the vascular surgery and interventional radiology market. Armin earned his M.B.A in economics and M.S. in engineering, regulatory and quality from the Rheinische Fachhochschule-Koeln university in Germany. Armin is based in Northern California. Read more.