Case Study
Regulatory Affairs: FSP Consulting Support – Ongoing Regulatory Affairs Consulting Solutions through an FSP-based Model Specifically Tailored to our Client’s Departmental Needs
Client:
A mid-sized biotechnology company based in the San Francisco Bay area with clinical and post-marketed products primarily focused on Oncology.
Key Issues:
Our client had recently experienced a higher-than-expected employee turnover within their Regulatory Affairs department throughout the previous eight months. This unforeseen turnover led to various departmental needs at multiple levels. The proactive timing of successfully addressing our client’s needs was critically important to avoid missing any pending regulatory deliverables and remaining compliant based on the growing number of expertise-related and production gaps.
Solution:
Over the next six months, BioPoint provided our client with seven senior director – executive level experienced consultants. Each consultant possessed the specific regulatory expertise and necessary industry experience to integrate seamlessly and immediately support our client’s Clinical, CMC, Ad Promo, and Labeling teams. Projects and deliverables included:
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- Manage and maintain new and existing IND and CTA submissions efforts
- Strategic regional labeling guidance and support
- Creating/revising new/existing CCDS
- Provide Ad Promo regulatory guidance (development, implementation, and ongoing compliance initiatives.
- Lead and support CMC Submission activities.
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Conclusion:
By understanding the demands and challenges our clients faced in conjunction with our years of Regulatory Affairs consulting experience, BioPoint provided our clients with an efficient, tailored FSP solution built to address their needs. BioPoint was able to assess, work with our client to mutually formulate a project plan with a working timeline and plan with our client, and then seamlessly offer and provide the expertise our clients needed when they needed it. Delivery efforts tailored around their specific business unit needs. This ongoing FSP model-based solution allowed our clients to meet their continuous regulatory obligations and deadlines while remaining compliant.