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Case studies

Regulatory Affairs


The world of medicine continues to change and evolve at an ever-increasing rate, and a BioPoint Regulatory Affairs expert will be there to help guide you through the also-evolving regulatory climate. BioPoint works with its clients providing the appropriate expertise every step of the way.

FSP Consulting Support - Clinical Trial Support & QA Compliance

Our client was looking to engage new external vendor partnerships with CRO’s and other service providers to support their rapid growth. The company had received fast track designation and would require a substantial amount of additional resources to prepare for several large Global Phase III trials. The small Regulatory team was in need of a variety of Clinical, Non-Clinical and CMC related support. Furthermore, existing Quality SOP’s were deficient and as the client’s clinical programs continued to grow rapidly, so compliance with requirements was also a concern.

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FSP Consulting Support - Medical Writing, Strategy & Submissions

Our client engaged BioPoint after a reorganization transformed the company from a Contract Manufacturing Organization to a fully functional specialty pharmaceutical company.

BioPoint’s client was looking to quickly scale up their newly formed in-house Regulatory division. Senior Regulatory leadership at the client required a flexible yet highly specialized partner to act as a Functional Service Provider. It was essential that this partner be able to meet evolving project deliverables, quickly assemble the necessary re- sources and integrate them either with their team or as stand-alone experts. It was also important to our client that they be able to maintain central oversight with real time access to BioPoint consultants.

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FSP Consulting Support - Strategy, CMC & Submissions

Our client was going through a large scale merger that resulted in a full hiring freeze across the many of the functional groups, including Regulatory Affairs. Due to the aggressive submission schedule, the timing of the acquisition was especially taxing on the Regulatory CMC team, because they were also preparing for a large tech transfer to a new manufacturer in the UK.

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FSP Consulting Support - Ongoing Regulatory Affairs Consulting Solutions through an FSP-based Model Specifically Tailored to our Client’s Departmental Needs

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. 

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