With the combined skills and knowledge of 50 experienced, multilingual specialists with global experience in regulatory submissions and drug safety programs, our team applies its expertise internationally and locally, facilitating the submissions process for the pharmaceutical and biotechnology industries. We draw on the knowledge we have gained from our our close work with regulatory agencies worldwide, including the EMEA and local country health authorities, and we ensure that all of our experts are trained to meet the requirements of the International Conference on Harmonization (ICH), EMEA/CPMP, the FDA and other important regulatory bodies.