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Case Study:

Regulatory Affairs #1

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Client:

A newly formed, mid-size New Jersey specialty pharmaceutical organization with a late stage pipeline of redesigned medications for CNS conditions.

Key Issues:

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.

Solution:

BioPoint assigned a dedicated Engagement Manager to tailor an FSP offering that addressed our client’s need for an accelerated yet flexible service delivery configuration. BioPoint’s Regulatory SME’s became familiar with our client’s products and processes allowing for a more streamlined assembly and deployment of resources as projects dictated.

BioPoint coordinated a comprehensive team of 2 Regulatory Strategist, 1 Regulatory Operations Project Manager, 2 Regulatory Writers, 2 Clinical Medical Writers, and an Epidemiologist (ISS/ISE). Working both onsite and remotely, the BioPoint team was able to effectively meet deliverables in the following areas over a twelve month period:

    • Regulatory Strategy – preparation, submission and communication with FDA/EMA, including representation of client at Health Authority meetings
    • Regulatory/Clinical Writing Support – author multiple eCTD modules, protocols, investigator brochure, ISS/ISE sections
    • Regulatory Operations/Project Management – vendor management/oversight, submission timeline planning/execution, formatting, document control and publishing

Conclusion:

By truly entering into an FSP alliance with its client, BioPoint was able to provide increased-control, full transparency of project deliverables and timelines, as well as substantial operational and cost efficiencies. Our client was in a position to address critical business needs while having the ability to more strategically transition to direct internal staff. BioPoint’s consultants remained available to assist with training as new employees were assimilated into the growing Regulatory group.