Syner-G BioPharma Group
Anuj Kumar is an experienced pharmaceutical professional currently serving as Senior Director at Syner-G BioPharma Group since April 2017. In this role, Anuj Kumar identifies and manages activities at CMOs/CROs, provides technical reviews for project documentation, and integrates the drug substance, drug product, and analytical planning into cohesive project timelines. Prior experience at Vertex Pharmaceuticals Inc. includes positions from Scientist I to Senior Scientist, where Anuj Kumar led formulation projects, developed solid oral dosage forms for clinical studies, and managed junior scientists. Anuj Kumar earned a Ph.D. in Pharmaceutics from the University of Wisconsin-Madison, which complements a robust career in drug development and regulatory support.
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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.