Syner-G BioPharma Group
David Malliaros is a seasoned consultant in the biopharmaceutical sector, currently serving at Syner-G BioPharma Group since March 2022 and at D. Malliaros Consulting, LLC since June 2020. With extensive experience in quality control and analytical operations, David held senior roles at Ultragenyx Gene Therapy as Senior Director of Quality Control and at Ironwood Pharmaceuticals as Director of Analytical Technical Operations. Previous positions include Director of Quality Control & Analytical Technology at Olympus Biotech and Associate Director at Stryker Biotech. David's career began at Biogen Idec as a Principal Scientist, where significant contributions were made to the Analytical Technology group and quality management of Avonex. David holds a Ph.D. in Biochemistry from the University of Massachusetts Lowell and a BS in Zoology from the University of Massachusetts Amherst.
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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.