Outsourcing has become the backbone of modern pharmaceutical and medical device operations. Sponsors increasingly rely on Contract Development and Manufacturing Organizations (CDMOs) for speed, expertise, and scalability. But as outsourcing continues to expand, so does regulatory oversight. The FDA and EMA have made it clear: while CDMOs perform the work, sponsors remain ultimately responsible for the quality and compliance of their products. Outsourced does not mean out of s

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In regulated industries such as pharmaceuticals and medical devices, document control is a critical component of compliance and...

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