Stage-Appropriate Quality Systems

By |2020-10-22T12:18:12-04:0010/22/2020|

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 [...]

Essential Characteristics of a Stage-Appropriate Quality System

By |2020-10-02T10:05:28-04:0008/18/2020|

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 [...]

Managing the Unexpected in Commercial Launch Planning

By |2020-09-22T14:51:55-04:0004/12/2019|

Managing the Unexpected in Commercial Launch Planning 2 Treatments, 1 Timeline Service Areas: Commercial Launch, Supply Chain, Quality, Enterprise IT Solutions, Commercial Systems, CRM, Medical Affairs Lifecycle Stage: Clinical Our client was an emerging biopharmaceutical company formed to commercialize a rare disease treatment in late-stage [...]

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