Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry.

ABSTRACT:

Background

Medical-product companies often outsource research and manufacturing needs to contracting or partnering organizations but then must manage a challenging patchwork of regulatory activities. A standalone regulatory agreement could clarify the relationships and responsibilities between companies working jointly on a single regulated product. This study explored the need for and current use of standalone regulatory agreements.

Methods

A survey instrument was developed using an implementation framework and disseminated to mid- to senior-level employees and consultants for sponsor and vendor companies in the medical products sector.

Results

Of 294 respondents, about half, primarily from companies with more than 200 employees, were familiar with standalone regulat

SUBMITTER: Wilhelm ME 

PROVIDER: S-EPMC11335966 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature