Stage-Appropriate Quality Systems development comes up directly or indirectly in essentially all our client work. Quality Management is essential for emerging biopharma companies in particular, who face significant technical, scientific, clinical, and operational uncertainties. There is always a question of how much, and how soon? We see some companies 'build for success' who [...]
Development of advanced therapies requires innovative manufacturing and process engineering. CMC (Chemistry, Manufacturing, and Controls) activities expand, evolve, and refocus over time. Companies move from toxicology studies through IND-enabling activities, and from preclinical and clinical testing through commercialization. Tasks and objectives change, but the need for speed, precision, flexible thinking, and CMC expertise [...]
CMC QA/The Quality System Webinar on 9/30/2020 Request the Recording Request the Presentation Biopharmaceutical companies developing innovative products must build a stage-appropriate quality system (QS) that ensures the right controls are in place. By doing this, they ensure patient safety and compliance while enhancing operational efficiency. The [...]
Scaling Clinical while Preparing for Commercial Supply Introducing Demand & Operations Planning Service Areas: Supply Chain, CMC, Clinical Operations, Commercial Launch, Finance Lifecycle Stage: Clinical Assumptions and decisions built into clinical trial design have a major impact on emerging companies’ capacity planning and supply strategy. Protocol [...]