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MANUFACTURING STRATEGY AND OPERATIONS

Your manufacturing programs must not only deliver materials reliably and reproducibly, but also provide the data and information required to support regulatory filings for clinical and market applications. Our experienced CMC program managers partner with you to develop strategies that meet your needs throughout all stages of your product’s lifecycle, from product candidate selection through commercialization.

Working with you, we can assemble and manage a team to coordinate and integrate critical CMC, non-clinical, pre-clinical and clinical activities from Clone to Clinic to Commercial, facilitate your workflow, and enable your product to move forward, faster. From cell line development and the procurement of raw materials to managing drug substance and drug product manufacturing and overseeing the packaging, labeling, and distribution of finished goods, our CMC team can help you:

  • Make sound operational decisions to support manufacturing, whether it be analyzing “make vs. buy” options, developing long-range manufacturing plans, identifying second sources, or designing production facilities
  • Develop appropriate communication tools and oversee communication between your CMC, non-clinical, pre-clinical, and clinical functions to enable company management and contractors to initiate and meet program milestones
  • Inform company management of timeline deviations in individual activities and propose mitigation approaches to reduce the impact on the overall program timeline
  • Prepare and manage product development plans and timelines, clearly identifying all required activities, key milestones, and their interdependencies
  • Identify, select, qualify, and manage contract service providers (CMOs, CROs, Testing Labs) for all your development, manufacturing, and quality needs, including developing and negotiating appropriate technology license, development, supply, technology transfer, and quality agreements
  • Assist in the design, construction, commissioning, and validation of your manufacturing facility, from preliminary technical and economic evaluations through supporting equipment and materials selection and procurement
  • For further support of your manufacturing needs, check out our Process Economic Modeling and bioTRAK Database services.

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