Some of the world's leading pharmaceutical, biological, and entrepreneurial companies have selected Abbott Molecular as their partner to develop and commercialize comprehensive, companion diagnostic products and strategies. Our teams of scientists and engineers, along with experts in legal, health economic and outcomes research, medical affairs, clinical affairs, regulatory affairs, and marketing are dedicated to ensuring successful collaborations.
Abbott's global regulatory infrastructure supports products in more than 130 countries. This broad portfolio has provided the experience necessary to guide discussions with regulatory agencies and design effective global clinical trials. These activities support the EU CE mark, FDA 510(k) clearance, and FDA PMA, Japan PMDA, and other approval processes.
We are investigating new biomarkers in oncology and other therapeutic areas. Learn more about our solutions pipline >>
To discuss a potential partnership, please contact us >>
Technology and Platform Capabilities
Abbott Molecular provides integrated services and custom assay development. Our technology platforms include instruments and assays for FISH (fluorescence in situ hybridization), sequencing, genetic analysis, real-time polymerase chain reaction (PCR) and are compliant with FDA cGMPs and global regulatory standards. AM's automated platforms are designed to provide consistent reproducibility and accuracy, system flexibility, and diverse testing menus.
Regulatory Knowledge and Experience
We provide the regulatory expertise to guide discussions with regulatory agencies and to design global clinical trials. This supports the EU CE mark, FDA 510(k) clearance, FDA PMA, Japan PMDA, and other approval processes. Abbott's global regulatory infrastructure supports products in more than 130 countries.
Our alliance managers provide the tools required to establish and maintain successful working relationships. Team governance, structure and roles, communication guidelines, and the issue escalation process support the collaboration. Experienced project managers drive the co-development project timelines, and ensure milestone achievement.