Celerion

Celerion is the premier provider of innovative early stage clinical research solutions. From facilities strategically located around the world, advanced scientific and technological expertise is applied to a full-range of integrated services, including Global Clinical Research (over 730 beds – 24 in-hospital, NDA-enabling clinical pharmacology), Clinical Pharmacology Sciences (Modeling and Simulation, Study Design and Protocol Development, Data Management, Biostatistics, Pharmacokinetics/Pharmacodynamics (PK/PD) and Medical Writing and Reporting), Global Bioanalytical Services (discovery through late stage), Regulatory Affairs, and Drug Development Services.

Developing biosimilars carries more risk, labor and expense than traditional generic drugs, and requires in-depth knowledge of biopharmaceutical drug development. Celerion’s experienced team of biosimilar experts have a proven track record in assisting clients control and manage this risk by providing access to integrated services to efficiently move a biosimilar drug along the path to marketing approval.
• Program development leadership and/or ad hoc consulting services spanning pre-clinical to Phase III
• Biosimilar and reference drug assay development and sample analysis
• Immunogenicity assay development and sample analysis
• Design, analysis and conduct of pharmacokinetic/pharmacodynamic (PK/PD) studies

For more information, visit www.celerion.com