Choosing a contract manufacturing (CM) partner for your clinical diagnostics kit is high on the list of business-critical decisions made during the commercialization process.
Outsourcing manufacturing is a valid strategic decision due to the significant capital expenditure required for in-house manufacturing. In addition to the costs of equipment, there is also the need to develop a Quality Management System (QMS) aligned with the required regulatory requirements, the hiring of personnel, and the acquisition of the appropriate certifications.
Due to the significant capital expenditure required, many companies choose outsourcing in order to redeploy their capital towards growing their business and developing new products. Your CM partner should have excellence in supply-chain management, extensive experience in transitioning assays to production, navigating changing international regulatory requirements, and solid QMS and documentation systems.
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