Syner-G BioPharma Group
Ingrid M. Levitt possesses extensive experience in regulatory affairs and research and development within the pharmaceutical industry. Currently serving as Associate Director Regulatory Affairs (CMC) at Syner-G BioPharma Group, Ingrid previously held the position of Senior Regulatory Affairs Manager (CMC) in the same organization. Prior to this role, Ingrid was a Regulatory Affairs Manager at Teva Pharmaceuticals, where a background in quality control and research and development was established as a Chemist and Scientist. Additional experience includes a position as an R&D Scientist at NSP and an internship at Sandoz, contributing to a well-rounded expertise in the field.
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Syner-G BioPharma Group
Syner-G BioPharma Group provides in-depth expertise across the three key elements of Chemistry, Manufacturing, and Controls (CMC): Regulatory Services, Technical Development, and Quality/IT. We call this CMC 360™. We also provide medical writing services, with expertise in authoring a variety of regulatory documents across a wide range of therapeutic areas and in all phases of development. Our regulatory affairs services include the development and implementation of global regulatory strategic plans, regulatory agency meeting support, and electronic submissions to regulatory authorities around the world. We have the skill set and experience to guide your prime asset through any development challenges and along the ever-changing maze of regulatory filing pathways, to a position of full compliance, and high quality. Our expertise spans small molecules, peptides, oligonucleotides, biologics, monoclonal antibodies, antibody-drug conjugates, and cell and gene therapy products.