Expertise
Preclinical Development of Cell Therapies
We know what it takes to develop a cell therapy product from bench to bedside. We will guide you through the key steps and requirements from GLP to IND.
Challenges and Opportunities in the US
Learn about the U.S. Food and Drug Administration, the Center for Biologics Evaluation and Research, and the Office of Tissue and Advanced Therapies. We stay on top of regulations and guidelines, so that you can move at the speed of today and tomorrow.
361 products, HCT/Ps
Minimally manipulated, intended for homologous use, autologous versus allogeneic in relatives. “361-only” opportunities and strategies to reach the scale.
RMAT: Regenerative Medicine Advanced Therapies designation
Is your agent a regenerative medicine therapy intended for a serious or life-threatening condition? Is the agent showing robust preliminary clinical evidence? If yes, let`s talk about RMAT.
Manufacture in Europe, clinical trials in LatAm, report in US
When you work with us you are in touch with a global network. Leverage our expertise in manufacturing, clinical research, and regulatory reporting to accelerate clinical translation.
Data management
Data is gold. From preclinical to clinical data, leverage our expertise in data collection, data management, and analytics.
Expertise
Preclinical Development of Cell Therapies
We know what it takes to develop a cell therapy product from bench to bedside. We will guide you through the key steps and requirements from GLP to IND.
Challenges and Opportunities in the US
Learn about the U.S. Food and Drug Administration, the Center for Biologics Evaluation and Research, and the Office of Tissue and Advanced Therapies. We stay on top of regulations and guidelines, so that you can move at the speed of today and tomorrow.
361 products, HCT/Ps
Minimally manipulated, intended for homologous use, autologous versus allogeneic in relatives. “361-only” opportunities and strategies to reach the scale.
RMAT: Regenerative Medicine Advanced Therapies designation
Is your agent a regenerative medicine therapy intended for a serious or life-threatening condition? Is the agent showing robust preliminary clinical evidence? If yes, let`s talk about RMAT.
Manufacture in Europe, clinical trials in LatAm, report in US
When you work with us you are in touch with a global network. Leverage our expertise in manufacturing, clinical research, and regulatory reporting to accelerate clinical translation.
Data management
Data is gold. From preclinical to clinical data, leverage our expertise in data collection, data management, and analytics.
Expertise
Preclinical Development of Cell Therapies
We know what it takes to develop a cell therapy product from bench to bedside. We will guide you through the key steps and requirements from GLP to IND.
Challenges and Opportunities in the US
Learn about the U.S. Food and Drug Administration, the Center for Biologics Evaluation and Research, and the Office of Tissue and Advanced Therapies. We stay on top of regulations and guidelines, so that you can move at the speed of today and tomorrow.
361 products, HCT/Ps
Minimally manipulated, intended for homologous use, autologous versus allogeneic in relatives. “361-only” opportunities and strategies to reach the scale.
RMAT: Regenerative Medicine Advanced Therapies designation
Is your agent a regenerative medicine therapy intended for a serious or life-threatening condition? Is the agent showing robust preliminary clinical evidence? If yes, let`s talk about RMAT.
Manufacture in Europe, clinical trials in LatAm, report in US
When you work with us you are in touch with a global network. Leverage our expertise in manufacturing, clinical research, and regulatory reporting to accelerate clinical translation.
Data management
Data is gold. From preclinical to clinical data, leverage our expertise in data collection, data management, and analytics.
Expertise
Preclinical Development of Cell Therapies
We know what it takes to develop a cell therapy product from bench to bedside. We will guide you through the key steps and requirements from GLP to IND.
Challenges and Opportunities in the US
Learn about the U.S. Food and Drug Administration, the Center for Biologics Evaluation and Research, and the Office of Tissue and Advanced Therapies. We stay on top of regulations and guidelines, so that you can move at the speed of today and tomorrow.
361 products, HCT/Ps
Minimally manipulated, intended for homologous use, autologous versus allogeneic in relatives. “361-only” opportunities and strategies to reach the scale.
RMAT: Regenerative Medicine Advanced Therapies designation
Is your agent a regenerative medicine therapy intended for a serious or life-threatening condition? Is the agent showing robust preliminary clinical evidence? If yes, let`s talk about RMAT.
Manufacture in Europe, clinical trials in LatAm, report in US
When you work with us you are in touch with a global network. Leverage our expertise in manufacturing, clinical research, and regulatory reporting to accelerate clinical translation.
Data management
Data is gold. From preclinical to clinical data, leverage our expertise in data collection, data management, and analytics.