Case Studies
Partners. Colleagues. An extension of your project team. These are just a handful of the things we strive to become with each of our clients, regardless of the size of the company or the complexity of the project.
But don’t just take it from us – have a look at some case studies to see the types of projects we get involved with and what our clients have to say about us.
Syner-G Helps Biotech Firm Successfully Advance Life-Saving Drug Through Manufacturing Startup and Clinical Trials
ABOUT The client is a clinical-stage biotechnology company focused on the phase III development of an anti-interleukin-6 monoclonal antibody therapeutic for the potential treatment of chronic active antibody-mediated rejection, the leading cause of long-term rejection...
Advancing Biotech Drug Development: Syner-G BioPharma’s Collaborative Approach to Chemistry, Manufacturing, and Controls
ABOUT The client is a U.S.-based clinical-stage biotechnology company using artificial intelligence (AI) and human data to transform drug discovery and development. The company uses machine learning to map the complex causes of diseases to develop proprietary drug...
Synthesizing Success: Syner-G’s Strategic Solutions for Elevating a Biotech Innovator
ABOUT The client is an emerging biotechnology company focused on developing and commercializing patient-friendly compounds to treat psychiatric and neurological disorders. The company is developing breakthrough non-hallucinogenic psychedelic derivatives with the...
Regulatory Expectations for Sterile Filtration Process Control
Sterile filtration is a critical process step in the production of injectable drug products and is used to remove microorganisms and particulates from a product stream to ensure purity and sterility of the product. Manufacturing controls are required to successfully...
Strategic CMC Development Partnership Enabling Timely Approval and Launch of a Breakthrough Product
Challenge The client lacked the internal resources to review and validate its strategy and approach to its first commercial program. They needed CMC support for their first drug which has “breakthrough” designation. The client embraced the outsourced model and knew it...
Partnership with a Canadian Pharma Organization resulted in savings in effort and material cost for time-critical clinical program
Challenge Syner-G was contracted by a Canadian Pharma Company to perform an emergency Investigation Audit triggered by an OOS of a time-critical Phase II supply at a CDMO site in India. Results Syner-G mobilized two of its experts (locally available in India)...
Partnership helped to reduce time to market by ensuring for U.S. based virtual Biopharmaceutical company
Challenge Syner-G was contracted by a U.S. based virtual biopharmaceutical company, who develops drug candidates for neurological diseases, to oversee the Quality and Compliance aspects for the Drug Substances and Drug Products in various phases of Product...
Virtual U.S. Biopharma company sees overall improvement in Quality Culture and ensured uninterrupted supply of compliant DS
Challenge Syner-G was contracted by a virtual U.S. Biopharma company to perform the responsibilities of their Quality Assurance function, locally in India. Syner-G Team was vested with responsibility (Quality and Compliance) of two CDMO sites in India for the...
U.S. Pharmaceutical company improved quality of overall documentation saving time and filing delays
Challenge Syner-G was contracted by a US Pharmaceutical Company to help improve the quality of submission documentation generated during the manufacture of a Drug Substance intended for Phase II trials. Client was outsourcing the manufacturing at a CDMO site in India...
Process improvements and in-person monitoring help U.S. pharmaceutical company achieve on time for Phase III clinical trials
Challenge Syner-G was contracted by a U.S. pharmaceutical company to oversee a 6 month, DS manufacturing as Person-In- Plant (PIP) and assist with preparation of associated submission documents related to Phase III clinical trial batches. The therapeutic agent was for...
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