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.
Please note that at the time these case studies were first published, Impact Pharmaceutical Services was an independent organization and not part of the Syner-G BioPharma Group.
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...
U.S. Based Independent Biotech Company Finds Success in Syner-G’s Capabilities in Manufacturing for Both Pre-Clinical and Clinical Trials
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...
Successful Partnership Improved Efficiencies and Reduced Overall Spend
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 is challenging. Managing the manufacturing, quality, and regulatory side of the processes (collectively called CMC – Chemistry, Manufacturing and Controls) takes a unique team with multiple areas of expertise.
Establishment of a Long-Term Medical Writing Partnership
Establishment of a Long-Term Medical Writing Partnership In 2009, IMPACT (now part of Syner-G BioPharma Group) was contracted by a mid-size global pharmaceutical company to prepare 2 Phase 3 clinical study reports (CSRs) for a biologic agent for the treatment of...
The Journey Leading to an Approved NDA
In 2010, following a referral from another company, IMPACT (now part of Syner-G BioPharma Group) was contacted by a mid-size biopharmaceutical company to assist them with an upcoming NDA for a new chemical entity in the treatment of an orphan condition. Over the next...
Expert Regulatory Affairs Services for a European-Based Client
In 2011, following referral from another company, IMPACT (now part of Syner-G BioPharma Group) was contacted by a small development stage pharmaceutical company located in the United Kingdom to assist them with pre-IND activities for a new chemical entity for the...
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