Event Recap: Stage-Appropriate Quality Systems

By |2023-06-28T11:34:04-04:0010/22/2020|

Event Recap: Stage-Appropriate Quality Systems Ashutosh Pandit, Consultant & Todd Applebaum, Managing Director 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 [...]

Essential Characteristics of a Stage-Appropriate Quality System

By |2023-01-03T16:18:28-05:0008/18/2020|

CMC QA/The Quality System Webinar on 9/30/2020 Essential Characteristics of a Stage-Appropriate Quality System Read the Event Recap 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 challenge is in establishing an appropriate [...]

Managing the Unexpected in Commercial Launch Planning

By |2022-02-08T10:27:08-05:0004/12/2019|

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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