Engagement Models Functional Service Program

Looking to streamline your external project management and avoid rapidly increasing rates? Bundle your outsourced projects with The FDA Group through our Functional Service Program (FSP) engagement model for substantial discounts. With our FSP, you get a single service provider for your projects and programs, reducing costs and complexity while receiving high-quality services from the industry's top talent.

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Bundle your RA/QA projects with us and save big with deeply discounted rates

We know life science teams often work with multiple outsourced project vendors, which can be costly and time-consuming to manage—especially as rates continue to increase. We believe life science teams deserve more than just transactional vendor relationships, but rather true partnerships that prioritize open communication, trust, and collaboration to effectively support all of their needs.

That's why we created the Functional Service Program (FSP), which enables you to consolidate your external projects with The FDA Group as a single-source vendor at a discounted rate. The more you outsource to us, the more you save. Our FSP model simplifies vendor management and reduces budget overruns while providing top-quality services.

Our FSP model addresses the later stages of the product lifecycle, where bundled service engagement offerings are hard to find. With discounts that scale with the size and duration of the service package, you'll reduce costs and management workload. 

Consolidate and simplify vendor management.

Our FSP enables you to consolidate some or potentially all of your externally-sourced RA/QA projects through a single vendor.

Save budget with deep discounts.

Discounts scale with the size and duration of the service package, reducing costs and management workload without sacrificing service quality. 

Total Quality Guarantee.

Our services are backed by a Total Quality Guarantee. If, for any reason, you are dissatisfied with any service, we will provide you with a full refund.

The Problem Rates are increasing and managing multiple vendors is time-consuming and frustrating

Life science teams—especially in the RA, QA, and adjacent functions—are spending more time managing more vendors who are charging higher rates. The growing burden and costs of vendor management are creating a host of challenges.

How many of these challenges resonate with you?

  • Inefficiency and lack of coordination
  • Costly and time-consuming vendor management
  • Budget overruns
  • Lack of visibility
  • Variable performance

The typical vendor relationship only focuses on immediate services, resulting in inefficiencies, delays, and mistakes. To avoid these issues, life science teams deserve true partnerships with their external firms that prioritize collaboration and shared goals.


Our Solution A one-stop-shop functional service program

To address these challenges all at once, we’ve taken the traditional FSP model of outsourcing—where a single vendor provides a set of related functions—to make it easier for RA, QA, and adjacent teams to manage projects and access the talent they need during the regulatory and post-commercialization stages of the product lifecycle.

Rather than coordinating a variety of projects with several vendors, you decide what you want to outsource to us to get rates that fit your budget and we’ll provide all the necessary resourcing and external support you need at a discounted rate.

With a single external support partner, you can more easily move and deploy the same resources across multiple functional areas, avoiding costs and delays due to additional onboarding and training.

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Functional service items

The sections below provide a selection of just some of the services you can bundle into a single, discounted service package over a given period. Contact us to express your interest and schedule a call to discuss service packaging, discounting, and our full range of services.

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Functional Service Area Quality Assurance

  • Quality system and SOP gap analysis
  • Deviation backlog reduction
  • Process analysis and improvement
  • Complaint and adverse event handling
  • Document control and change management
  • CAPA management and follow-up
  • Investigation, action plan, and effectiveness checks
  • Risk assessments and risk mitigation strategies
  • Non-conformance/deviation investigation management support
  • QMS development and remediation
  • Regulatory compliance support (e.g., ISO, FDA regulations)
  • Quality resource/workforce management (e.g., temp and permanent)
  • Internal and external audits, including, but not limited to:
    • Mock Pre-Approval Inspections (PAI) and mock FDA audits
    • GMP, GCP, GLP audits
    • Mock Notified Body Inspections
    • Mock recalls
    • Vendor/supplier audits
    • MDSAP audits
    • Site investigator and clinical audits

Functional Service Area Regulatory Affairs

  • Preparation and submission of New Drug Applications (NDA), Biologics License Applications (BLA), or Premarket Approval Applications (PMA) to FDA, or Abbreviated New Drug Application (ANDA)
  • Preparation and submission of regulatory reports and documents, such as adverse event reports and annual reports
  • Regulatory affairs resource/workforce management (e.g., temp and permanent)
  • Monitoring of regulatory developments and guidance and providing advice to clients on regulatory compliance and issues
  • Preparation of regulatory submissions for investigational devices and clinical trial applications
  • Preparation of regulatory submissions for orphan drug designation
  • Preparation and submission of annual reports and amendments to regulatory agencies
  • Preparation of labeling and promotional material in accordance with FDA regulations and guidance
  • Development and implementation of regulatory strategies for product development and commercialization
  • Document control and change management
  • EU MDR and IVDR compliance

FUNCTIONAL AREA Commissioning, Qualification & Validation

  • Validation Master Plans (VMPs)

  • Design Qualification (DQ)

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Equipment Validation

  • Software Validation

  • Process Validation

  • Commissioning, qualification and validation resource/workforce management (e.g., temp and permanent)

How it works

Bundling services to receive deep discounts with us is easy.



1. Express your interest.

Get in touch with us to let us know you’re interested in an easier, more cost-effective way to procure external services.

2. Customize your service bundle.

We’ll work together to select the projects you'd like to outsource to us to receive discounts over a desired period.

3. Consolidate your vendors and receive deep discounts.

You’ll get a service package that gives you better support at lower rates.

Why work with The FDA Group?

  • Exclusive life science focus and expertise
  • Dedicated account management team
  • Right resource, first time (95% success)
  • 97% client satisfaction
  • Total Quality Guarantee

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FUNCTIONAL SERVICE PROGRAM Contact us and get the conversation started.

Our resources can be utilized to meet the wide range of requirements throughout the life sciences, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.

Please contact us to learn more about bundling services to receive discounts through our FSP engagement model. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.