Challenges of Biopharmaceutical Companies
Biopharmaceutical firms are faced with huge challenges as they commercialize their drug discoveries. Daunting technical challenges, complex regulatory requirements, and the need to invest significant capital before the success of a drug is in-hand all dramatically raise the level of internal risk. There are also numerous multidisciplinary skills that are inherently required to commercialize biopharmaceuticals.
As regulatory requirements grow increasingly stringent, operational consistency and reliability can have a great impact on compliance. Additionally, the effective management of operations over and above GMP requirements, in areas such as manufacturing (CMC), supply planning, materials management, tech transfer and change control, is crucial to meeting milestones and ensuring quality.
Reliable Execution to Manage Critical Processes Effectively
Successful development, launch, and sustainable supply depend upon bridging knowledge and skills across corporate functions. Groups as varied as process development, quality, manufacturing, materials sourcing, marketing, and finance must work together as teams. We work with your organization to design and manage critical processes the way work is actually performed - across traditional functional boundaries, and across the supply network.
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