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Put our experience to work for you! Introduce your product to the market faster. Our consulting services consist of the Product, Process and Analytical Development assistance to guide your development, and the quality, regulatory, supply chain and program management expertise to pave your way to a faster approval and more profitable launch.
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We can help you to navigate the complex regulatory landscape, develop and implement Quality Systems, and carry out audits and investigations to ensure compliance to cGMPs. We have the experience to help you manage the unique Quality and regulatory issues of proteins, monoclonal antibodies, and cell therapy products.
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Inefficient production and business processes cost companies millions every year and divert resources better used to improve profitability or investment in new products. Cell therapy products in particular have significantly higher cost of goods compared to recombinant proteins and antibodies. We can help you launch with a more competitive cost structure, or help you to reduce your cost of goods for an already approved product. |
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