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

Ron Kraus

Binesh Prabhakar

Tom Puthiaparampil Ph. D

Stephen F. Coté

Prabu Nambiar

Nancy Gasper Smith

Neil Butera

Michael L. Miller

lata harish

Kevin Swiss

Karen Casey

Jay Samudralwar, Ph.D.

Ed Ciolkowski

Drew Barlow, MPH

Clinical Research Team

Leadership Team

Project Management

Regulatory Affairs and Compliance

Finance and Accounting

Human Resources and People Operations

Consulting and Advisory Services

Teams at Syner-G BioPharma Group