Our team has extensive experience from having worked in both regulatory agency and industry positions with a wide variety of products, to include innovative therapeutic proteins, therapeutic vaccines, monoclonal antibodies, somatic cell therapies, tissue-engineered products, and biological generics.
In terms of “top ten” activities that we engage in:
Our consulting expertise spans the biopharmaceutical development process from discovery through preclinical and clinical studies to post-marketing activities.
A unique aspect of our consulting service is its linkage to the resource specialists distributed across a Contract Research Organization that provides many of the supporting product development services, including molecular pharmacology, safety pharmacology, tissue cross-reactivity screening, immunoassay development, toxicology, clinical research, central laboratory, and specialized biomarker facilities. Accordingly, biopharmaceutical product development is provided by an extended group of specialists with a high level of applied experience providing the client with a “case-by-case” scientific and regulatory-supported approach rather than a “box-checking” approach.
