Key Considerations for Selecting an FSP Partner

This white paper outlines key considerations for selecting a Functional Service Provider (FSP) partner for regulatory publishing. It emphasizes the importance of regulatory submissions in ensuring product safety and efficacy, which must comply with strict guidelines from health authorities like the FDA and EMA. The document details the necessity for a global footprint in choosing an FSP partner, highlighting the advantages of regional expertise and cost-effective resources. It explains the follow-the-sun model, which allows for continuous operations and optimized resource allocation, thus reducing delays in the submission process. The paper also discusses the need for FSP partners to stay updated with evolving regulatory requirements and data standards, ensuring compliance with the latest guidelines. Additionally, it presents the benefits of flexibility in resource management and the importance of selecting a partner with a proven track record in delivering compliant projects. Overall, the document serves as a comprehensive guide for sponsors navigating the complexities of regulatory submissions.