by Syner-G | Nov 1, 2023 | Case Studies
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...
by Scott Farr | Sep 20, 2023 | Case Studies
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)...
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...
