Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry.
Mary E WilhelmNancy Pire-SmerkanichFrances J RichmondPublished in: Therapeutic innovation & regulatory science (2024)
Standalone regulatory agreements are becoming more common but are not yet implemented fully by most companies. Their usefulness and content appeared to depend upon the type of partner, the complexity of the relationship and the availability of internal expertise and support.
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