Quality Assurance: We have a robust understanding of how the foundation and overarching responsibilities of Quality Assurance enable compliance with health authorities worldwide. Knowing where to go next in the process, and that all roles need a seat at the table is just the beginning.

Risk Management: Establishing a proactive approach rather than a reactive approach to product development includes risk management across the bench to bedside landscape. We combine our experience with guidance from Health Authorities and the goals of each client to enable efficient scalable processes.

Data Management: We have a dedicated data management team with the flexibility to support phase 1 to phase 4 trials. We provide side-by-side client support from the establishment of the URL through validation, production, and data mining.

Pharmacovigilance: From first in humans through post-marketing, addressing pharmacovigilance is a critical piece of product development. Let us help you navigate the process.

REMS: How do Risk Evaluation and Mitigation Strategies (REMS) programs work? What are the implications? What responsibilities do organizations have when they have been assigned a REMS by the FDA? We can help. We work with RIC (REMS Industry Consortium), on cutting-edge solutions.

Mergers and Acquisitions: After the ink is dry on the agreements, that is where we provide the plans for the integration of data, departments, and personnel. Our expertise and due diligence ensure that any health authority or regulatory issues are addressed in a timely manner.