Program Management & Regulatory Submissions

Projects can enter our pharmaceutical development pipeline at various stages of maturity. Our seasoned staff will quickly assess and determine gaps or high risk points for Chemistry Manufacturing and Control (CMC) and regulatory strategy in order to best advise our client. Our project managers have direct experience advancing drugs from concept through Food and Drug Administration (FDA) licensure, setting up type 2 FDA meetings, preparing meeting packages, and identifying strategic questions that could impact development and lifecycle management costs. We have experience developing nonclinical safety and efficacy studies that will answer key development questions and expedite FDA review. We have experience writing, hyperlinking and submitting investigational new drugs (INDs) in electronic Common Technical Document (eCTD) format and submitting IND updates, even through phase 3 clinical studies.