RAPS spoke with Patricia Cash and Joseph Quinn, presenters at our Biologics CMC: Regulatory Challenges and Trends, a workshop on 12-13 March and 10-11 October 2024, on got their top tips regarding the common problems in biologics CMC, pitfalls that often affect CMC experts trying to better navigate regulatory affairs, and more.
ensure that your biologic or biosimilar product remains safe and consistent from drug discovery through technical development and production, and ultimately through regulatory approval and commercialization.
What additional advice would you offer your regulatory affairs colleagues?
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Brooke Keith
Marketing
Denver CO
United States
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