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.

Biotechnology

Health Care

Medical Devices

Pharmaceutical

Syner-G BioPharma Group

Syner-G BioPharma Group's headquarters in Framingham, MA, United States

Ron Kraus

Ray Forslund

Libby Russell

Tom Puthiaparampil Ph. D

Stephen F. Coté

Neil Butera

Kevin Swiss

Karen Casey

Ed Ciolkowski

Drew Barlow, MPH

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People (16)

Ron Kraus

Drew Barlow, MPH

Karen Casey

Traci Beevers

Michael L. Miller

Lauren Sweeney, PharmD

Prabu Nambiar

Stephen F. Coté

Melissa Dunne

Gregory Demos

Serghei Balan

Ray Forslund

Mao Yin

Binesh Prabhakar

David Malliaros

Anuj Kumar

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