BSSI can help you navigate the complicated and dynamic regulatory process. Whether you have a drug submission heading toward the Center for Drug Evaluation and Research (CDER), or you have a biologic submission heading toward the Center for Biologics Evaluation and Research (CBER), we can improve your likelihood of success. Our staff works with your scientists and clinical investigators during pre-clinical and Phase I, II, III and IV clinical trials to aid in study design, data management and statistical support.

Our team provides expert guidance and the supportive analytical services required to produce a high-quality new drug application (NDA) and draft appropriate regulatory responses. BioStat Solutions, Inc offers validated statistical analyses, along with the generation of tables, figures and listings in accordance with regulatory requirements. For details on how our statistical analyses are conducted in accordance with FDA guidelines: Regulatory Compliance.

We have expertise in a wide-range of biostatistics methods. If your submission has a genetic component, we offer expert services in PGx analysis.

Contact us for more information about these and other capabilities.