Introducing our Functional Service Program (FSP)

At The FDA Group, we understand that life science teams often work with multiple vendors to get their projects done, which can be costly, time-consuming, and complex to manage.

We believe teams deserve more than just transactional vendor relationships. They need true partnerships that prioritize open communication, trust, and collaboration to effectively support all of their needs.

That’s why we’ve developed a unique Functional Service Program (FSP) that consolidates your externally-sourced projects, streamlines vendor management, and offers significant discounts, all while maintaining high-quality services from top industry talent.

You simply tell us what you'd like to outsource to us, and we'll offer you a substantial discount. We will then create a plan to resource and execute those projects with progressively lower rates. The more work you outsource to us, the more money you save.

As your single, reliable resourcing partner, we’ll plan, coordinate, and execute projects and programs at a fraction of the cost and complexity you currently manage. You can easily move and deploy the same resources across multiple functional areas, avoiding costs and delays associated with onboarding and training.

Our FSP model caters to the later stages of the product lifecycle, where bundled service engagement offerings are scarce. Similar to a traditional clinical FSP, our outsourcing model streamlines your external work and gives you a single point of accountability and integrated service offering.

We offer discounts that scale with the size and duration of the service package, which will help you reduce costs and management workload while providing reliable service backed by our Total Quality Guarantee.

If you're interested in learning more about this bundled engagement option, please contact us to schedule a brief discussion. We'll answer your questions, identify potential bundled service opportunities, and guide you through the next steps.

» Read on for a more comprehensive overview of the problem our FSP solves, how it works, and the kinds of services you can bundle through it. If you prefer a hard copy to save and circulate, you can access and download a PDF version of this overview here.

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

Managing multiple vendors means dealing with inefficiency, miscommunication, budget overruns, and a lack of visibility. Traditional vendor relationships can also lack coordination and alignment, causing delays and mistakes.

Life science teams, particularly those in Regulatory Affairs (RA), Quality Assurance (QA), and adjacent functions, are facing rising costs and spending more time managing multiple vendors.

This is causing a host of challenges, including:

• Inefficiency and lack of coordination: Working with multiple vendors can result in inefficiency, miscommunication, and a lack of coordination between service providers and internal staff.

• Costly and time-consuming vendor management: Managing multiple vendors is resource-intensive, requiring significant effort to ensure that projects are completed as required.

• Budget overruns: Each vendor may have a different pricing structure, which can be difficult to reconcile and often leads to budget overruns.

• Lack of visibility: Without a clear and unified view of the work being done by different vendors, it can be difficult to understand project status and identify areas needing attention.

• Variable performance: Different vendors may have different strengths and weaknesses, and ensuring all vendors are held accountable for delivering quality results only adds to the management burden.

Beyond these challenges, we believe the typical vendor relationship focuses solely on delivering immediate services, with little consideration for the broader goals of the life science team. This can lead to a lack of coordination and alignment between vendors, resulting in inefficiencies, delays, and mistakes that can negatively impact project success.

And without open communication and trust, it can be challenging to pivot or adjust course as needed, further exacerbating these issues. As such, it’s become crucial for life science teams to develop true partnerships with external firms that are invested in project success and work collaboratively towards achieving 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 QA, RA, 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. We'll provide all the necessary resourcing and external support you need at a discounted rate — a rate you're unlikely to find elsewhere without compromising the quality and experience of the professionals provided.

This approach makes management more streamlined and efficient for you while saving considerable budget, all without sacrificing service quality and incurring the associated risks of working with lower-tier service providers.

Functional service items 

The lists 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.

Quality Assurance

• 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 

• Quality system and SOP gap analysis 

• Quality resource/workforce management (e.g., temp and permanent) 

• QMS development and remediation 

• Non-conformance/deviation investigation management support 

• Deviation backlog reduction 

• Process analysis and improvement 

• Investigation, action plan, and effectiveness checks 

• Risk assessments and risk mitigation strategies 

• Document control and change management 

• Regulatory compliance support (e.g., ISO, FDA regulations) 

• Complaint and adverse event handling 

• CAPA management and follow-up

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) 

• Regulatory affairs resource/ workforce management (e.g., temp and permanent) 

• Preparation of regulatory submissions for investigational devices and clinical trial applications 

• Preparation and submission of annual reports and amendments to regulatory agencies 

• Development and implementation of regulatory strategies for product development and commercialization 

• Preparation and submission of regulatory reports and documents, such as adverse event reports and annual reports 

• Monitoring of regulatory developments and guidance and providing advice to clients on regulatory compliance and issues 

• Preparation of regulatory submissions for orphan drug designation

Commissioning, Qualification, and Validation

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

• DQ, IQ, OQ, PQ 

• Equipment Validation 

• Software Validation 

• Process Validation

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 feel comfortable with us bidding on 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.

Interested in learning more about our FSP engagement model? Visit our engagement model page and get in touch with us however you prefer:

Web form | US Toll-Free: 1-833-FDA-GROUP | International: +001 508 926 8330 | Email: info@thefdagroup.com