Functional service provider & fractional C-suite

Senior life science leadership, embedded in your team

Bracken's Functional Service Provider (FSP) model places experienced executives and operators inside biotech, pharma, and medical device companies, in the roles your program can't leave empty.

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We can support your team, or be your team.

Interim CEO The most senior seat our consultants have filled
IND, NDA, BLA Filings prepared from inside client teams
Seed to F500 Client scale, from startups to Fortune 500

What a Bracken FSP Engagement Covers

A functional service provider takes on a whole function inside your company, not a single deliverable. Bracken professionals integrate into your organization and operate as an extension of the internal team, giving you high-level expertise on a flexible basis while you keep accountability for the decisions that drive the business forward.

  • Fractional or interim Chief Medical Officer
  • Fractional or interim Chief Scientific Officer
  • Fractional Chief Financial Officer
  • Head of Regulatory and embedded regulatory team
  • IND, NDA, and BLA filings, and FDA meeting leadership
  • In-house clinical operations and medical operations leadership
  • Clinical trial design, protocol development, and phase strategy
  • Program management leadership
  • Interim CEO and executive leadership support
  • Long-term operating partnerships across functions

Bracken is a concierge-style life sciences consultancy. When a program needs one advisor on a specific question, that runs through our consulting practice. When it needs someone to own a function week to week, that is the FSP model. Regulatory leadership placed through FSP draws on the same bench as Regulatory Affairs.

How an FSP Engagement Grows: A Client Scenario

A company developing a novel nuclear medicine diagnostic asked Bracken to help design its Phase 1 clinical trial. The engagement grew from there.

  1. 1

    Deep dive

    Our team worked to understand the product and its development requirements before any design work began.

  2. 2

    First protocol

    Bracken built and designed the client's first clinical protocol.

  3. 3

    First IND

    Through the FSP engagement, Bracken became the client's embedded regulatory team and filed its first IND.

  4. 4

    Phase 2 strategy

    Now serving as in-house clinical operations, medical operations, and program management leadership, Bracken is shaping the Phase 2 clinical strategy.

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Former C-suite executives, physicians, regulatory leads, and program managers. Full profiles and credentials.

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Client Case Studies

Published engagements, from embedded clinical development support to regulatory readiness and trial rescues.

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Questions

What is a functional service provider (FSP) in life sciences?
A functional service provider takes on a whole function inside a company rather than a single project. At Bracken, that means embedding experienced experts directly into client teams to fill leadership and operational roles, such as Chief Medical Officer, Chief Scientific Officer, Chief Financial Officer, Head of Regulatory, or program management lead. Our people operate as an extension of the internal team, and the client keeps accountability for the key decisions that drive the business.
Which roles can Bracken fill through the FSP model?
Bracken consultants regularly serve in functions typically held by Chief Scientific Officers, Chief Medical Officers, Chief Financial Officers, Heads of Regulatory, and program management leadership, as well as in-house clinical operations and medical operations. In some engagements, our experts have stepped in to support executive leadership as new or interim CEOs.
How is an FSP different from a CRO or a full-time hire?
A contract research organization typically carries out defined trial work under its own processes. Bracken's FSP model places senior people inside your organization, in the roles where strategy is set and decisions are made. Compared with a full-time executive hire, it gives you that level of experience on a flexible basis, without the lead time of a search. Clients can use both, with Bracken leadership working alongside their CRO.
Can Bracken's FSP team file INDs and lead FDA meetings?
Yes. FSP engagements often include filing INDs, NDAs, and BLAs, and supporting and leading meetings with the FDA. In one engagement, Bracken became a nuclear medicine client's embedded regulatory team and filed the company's first IND. See Regulatory Affairs for the wider capability.
How does an FSP engagement start, and can it scale?
Most start with one defined need: designing a protocol, preparing a filing, or covering a leadership gap. Many grow into long-term partnerships as Bracken takes on regulatory, clinical, operational, and program management functions. The scope can expand or contract as the program moves through development, and Bracken works with companies from seed-stage startups to the Fortune 500.

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