SERVICES Quality Assurance

Need expert help identifying and remediating shortfalls within your Quality Management System (QMS)? Need to build or augment your Quality Assurance team with top talent? We help thousands of life science companies outsource their QA projects and fill specialized roles through convenient staff augmentation and recruitment.

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FUNCTIONAL AREA Quality Management Systems (QMS)

Our quality and compliance specialists have extensive knowledge and experience in relevant regulations, guidances, and best practices related to quality system management throughout the regulated life science industries.

  • GxP Audits

  • QMS Process & Procedure Development

  • Gap Assessments

  • QMS Remediation

  • Quality Unit Resourcing

Case Study: International Auditing Project with Worldwide Consultant Resourcing

Learn how The FDA Group partnered with a healthcare product company to support a series of international Quality Audits to assess both Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) throughout the United States, Europe, Asia, and the Middle East.

  • The FDA Group identified and selected almost a dozen auditors offering specific expertise to address the particular needs in various international locations.
  • The audits provided insight into particular areas of concern for sites around the world. Each of the GMP and GCP audits, and subsequent reports generated, offered company and department leaders clear and practical information regarding the strengths and weaknesses of their quality system as they related to both national and international quality standards.
  • The company continues to engage The FDA Group for its GMP and GCP auditing needs.

Read the full case study (PDF) »

Functional Area Non-Conformance & CAPA Management

Our quality, manufacturing, CAPA, and supplier quality experts conduct comprehensive process reviews and analyses to ensure all compliance gaps are closed no matter where they may be.

  • Non-Conformance/Deviation Investigation Management Support

  • Process Analysis & Enhancement

  • Investigation, Action Plan, & Effectiveness Check 

Case Study: Deviation Backlog Reduction, CAPA Management, and Long-Term Staff Augmentation

Learn how The FDA Group partnered with a multinational pharmaceutical company to support its QMS remediation efforts.

  • This project principally included deviation and CAPA backlog activities, significant corrective and preventive remediation throughout the quality system, and extended support to assist in staff onboarding, training, and maintaining the continuity of improvements made across the QMS. 
  • The FDA Group, in cooperation with the company, developed a strategy that consisted of mobilizing 17 external resources to carry out work projects over an initial three-month timeframe.
  • The FDA Group accomplished its goal of eliminating all backlogs on time and under budget.

Read the full case study (PDF) »

Functional Area Regulatory Compliance

Move your organization forward while maintaining a continuous and complete state of regulatory compliance. From regulatory observation responses to inspection readiness, our large staff of compliance specialists can tackle virtually any regulatory challenge.

  • Regulatory Observation Responses & Remediation

  • PAI & Inspection Readiness

  • Internal Audit & Remediation Services

Explainer: FDA Form 483, Warning Letter, and Consent Decree Response Services

Download our comprehensive service explainer to learn how The FDA Group provides expert assistance with FDA regulatory enforcement actions. We help companies develop effective responses to 483 observations and Warning Letters through CAPA planning, root cause analysis, and strategic remediation.

Our approach is not just about addressing immediate responses and compliance issues; it's about fortifying your quality systems and processes against future risks. By partnering with us, you can expect a robust and compliant recovery strategy you won't find elsewhere. The following is a detailed breakdown of our typical response process—however, it can be adapted to fit exactly the kind of support you need.

Download our service explainer (PDF) »

Case Study: International PAI Audit Preparation & Remediation Project

See how The FDA Group partnered with a large healthcare product company to support a Pre-Approval Inspection (PAI) audit preparation project and subsequent quality system remediation efforts at a site within the European Union (EU).

  • The company engaged The FDA Group to utilize its quality system experts, who combined, brought more than eight decades of regulated expertise to plan and execute a Q&R audit preparation project and close quality system gaps through deviation reduction activities.
  • The FDA Group was pleased to announce project completion on time and 15% under the estimated budget.

Read the full case study (PDF) »

Engagement Models

 

Get access to expert consultants as well as contingent or direct hire candidate search and placement services. We specialize in the entire range of the resourcing process, giving you a breadth of expertise that has become increasingly hard to find in the life science industry.

ENGAGEMENT MODEL Consulting Projects

Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.

Contact us » Learn more »

ENGAGEMENT MODEL Staff Augmentation

Get contracted full-time consultant (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.

Contact us » Learn more »

Engagement Model FTE Recruitment

We rapidly identify and place direct hire candidates in a variety of positions and job functions. Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates, especially in specialized, competitive areas.

Contact us » Learn more »

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

Read our brochure »

Our Proven Process

Introductory Conversation

  • About Us
  • About You
  • Scope Of Work

Resources Definition

  • Background And Expertise
  • Location Of Resource
  • Rate Rightsizing

Proprietary Resource Selection Process

  • In-House Subject Matter Experts
  • Recruiting Team External Search
  • Resource Identification

Resource Presentation

  • CV And Rate
  • Perfect Match Summary
  • Interview Call Coordination

Agreement Processing

  • MSA And Addendums
  • Supplier Qualification
  • Kickoff Coordination

Account Management

  • Project Management Of Resource
  • Satisfaction Management For Client
  • Total Quality Guarantee

Contact us and get the conversation started.

Our resources can be utilized to meet the wide range of quality assurance requirements, 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 fulfilling specific quality assurance resourcing needs. 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.