Syner-G BioPharma Group
Drew Barlow, MPH, has extensive experience in regulatory affairs and compliance within the pharmaceutical industry. Currently serving as the SVP, Head of Regulatory Partnerships at Syner-G BioPharma Group, Drew has previously held leadership roles at Alkermes and Vertex Pharmaceuticals. With a background in public health education and biology, Drew has a proven track record of authoring regulatory CMC submissions and providing strategic guidance to teams for NDA/MAA preparation activities. Additionally, Drew has experience working for the US Food and Drug Administration and the U.S. Public Health Service Commissioned Corps.
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.