Nitrosamine Impurities Affecting Drug-Drug Interaction Studies – Learn More

Product-labeling study experience & expertise to support your next drug marketing application

Partner with us on your next product labeling study.

With over 50 years of experience and expertise in conducting early clinical research, we can be your full service clinical research organization (CRO) partner. Celerion collaborates with pharmaceutical companies seeking market approval for new drugs. Our clinics excel at conducting product-labeling studies such as drug-drug interaction, cardiac safety, bioequivalence and bioavailability, ADME, and renal and hepatic studies, all required to support drug-marketing applications.

Based on our considerable knowledge in this area, Celerion is able to proactively create efficient and cost-effective packages of product labeling studies, thereby allowing the same team of scientists to apply knowledge of the drug across all studies when performing the conduct and analysis.

On site at our clinics, we also provide bioanalysis for small and large molecules (for pre-clinical and human studies). Our full service offering includes protocol design, data management, monitoring and PK/Statistical analysis. We also have extensive partner site relationships for your small patient studies. Let us share our experience as you plan your next product labeling study.

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CROLA-S-2024 1

CRO Leadership Awards 2024

CRO Leadership award winner for 9 years in a row. Thank you to our clients for your continued support.

Celerion Overview

Product Labeling Studies

ADME Studies

QT Assessment in Early Drug Development: The Long and the Short of It

pH-Dependent Drug-Interactions with Acid Reducing Agents

Revised FDA Renal Impairment PK Study Guidance

Evaluating Therapeutic Proteins in DDI Studies

Rifampin Drug–Drug–Interaction Studies

Onsite Pharmacy Compounding