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Dr. Burch has been with Nuventra since May 2014 with a primary focus on regulatory affairs, medical and scientific writing, and project management, and currently oversees Nuventra’s Regulatory Affairs and Scientific Writing department. Dr. Burch has participated in numerous IND, NDA (505(b)(1) and 505(b)(2)), and BLA submissions across a multitude of drug classes, routes of administration, and therapeutic areas. Dr. Burch’s experience includes overall regulatory strategy; client representation at FDA meetings; on-site assessments and gap analyses for client development programs; authoring clinical, nonclinical, quality (i.e., Chemistry, Manufacturing, and Controls), and administrative modules of regulatory submissions; and authoring clinical study reports, manuscripts, and a diverse array of other regulatory, scientific, and technical documents.