Syner-G BioPharma Group

Syner-G BioPharma Group

Pharmaceutical Manufacturing

Framingham, MA 7,959 followers

To enable our clients to achieve success and enhance human health while inspiring our colleagues to excel! #weinspire

About us

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.

Industry
Pharmaceutical Manufacturing
Company size
201-500 employees
Headquarters
Framingham, MA
Type
Privately Held
Specialties
cGMP Solutions, Regulatory Science for Pharm Development, CMC Formulation Development, Post-Approval CMC, Medical Writing Services, Biologics, Cell and Gene, Project Management, Regulatory Services, and CMC

Locations

  • Primary

    100 Pennsylvania Avenue

    Framingham, MA 01701, US

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  • 79 T.W. Alexander Drive

    Building 4401, Suite 101

    Research Triangle Park, NC 27709, US

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  • P. No. 15, W-Block, 2nd Floor

    North Main Road Anna Nagar West Extension

    Chennai, 600 101, IN

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  • 6000 Spine Road

    Suite, 201

    Boulder, CO 80301, US

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