Our client is a global pharmaceutical company, headquartered in the USA, developing, and commercializing innovative proprietary medicinal products. The company had recently acquired eight marketed Oncology products, encompassing both pharmaceuticals and biologics. While the acquisition was a strategic move to expand their portfolio, the company faced immediate challenges regarding regulatory compliance. With the absence of an internal Regulatory Affairs (RA) team capable of handling FDA compliance and the life cycle maintenance of the acquired products, the company sought a dependable Regulatory partner to help navigate these complexities.

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