For many small to midsize biopharma companies in today's drug market, adherence to FDA regulations when bringing a new biologic or synthetic drug to market is not optional, it is required. A company can risk wasting valuable time, money, and resources if certain aspects of Quality Management are not built into the early phases of the product development and launch processes and if the organization does not follow current Good Manufacturing Practices (cGMPs). This insight brief offers thoughts on what companies need to know.
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