Functional Service Program

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.

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.

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.

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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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