Services Overview

Clinical Trials

Regulatory

Medical & Pharmacovigilance

Nonclinical Safety

Data Management & Biostatistics

Chemistry, Manufacturing and Controls

Medical Writing

Quality Assurance

Project Management

Investigator Registry

Services: Chemistry, Manufacturing and Controls

Our CMC development team provides technical expertise for the selection and qualification of pharmaceutical active ingredients suppliers, pharmaceutical product development, and dosage form development. In addition, our pharmaceutical professionals provide management of the manufacturing, packaging, and labeling of products, as well as documentation of clinical trial material.

Our in-house CMC specialists are uniquely qualified to assist in managing full CMC development programs, from concept to commercialization. These activities include pre-formulation, formulation/scale-up, production planning, stability studies, and specification development, as well as in-process and release testing and validation. We also participate at FDA meetings to present the product development strategy and conduct on-site cGMP and GLP audits of manufacturing facilities, to determine compliance with regulatory standards.

By integrating the CMC and clinical supplies efforts into the overall drug development program, we ensure that products of the highest quality are available for clinical trials in a timely fashion.