by Scott Farr | Sep 20, 2023 | Case Studies
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...
by Scott Farr | Sep 20, 2023 | Case Studies
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...
by Scott Farr | Sep 20, 2023 | Case Studies
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...
by Scott Farr | Sep 20, 2023 | Case Studies
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...
by Syner-G | Sep 18, 2023 | Case Studies
About Yumanity Therapeutics, headquartered in Boston, was established in December 2014 as an independent biotechnology company focused on drug development targeting neurological diseases where protein misfolding is a key concept, such as Alzheimer’s, Parkinson’s...
by Syner-G | Sep 11, 2023 | Case Studies
About the study The client is a small, clinical-stage oncology company focused on developing novel medicines for metastatic breast cancer patients. Challenge Advancing a new registration-ready drug from discovery and phase 1 clinical trials to phase 3 clinical trials...