CONSULTING

GxP Services

From early discovery to managing your global portfolio, address all your GxP compliance needs and concerns with Advarra, wherever you are in the development journey.

GxP Info Sheet

Your Trusted and Proven Partner for Global GxP Quality Compliance

Rely on Advarra to establish, plan, review, or correct any GxP quality requirements for your current and future studies. With a flexible engagement model, collaborative approach, and established reputation, Advarra can support GxP excellence in research organizations of any size around the world.

Comprehensive GxP Expertise You Can Trust

You need a partner that can easily understand your needs. Advarra is one of the largest GxP consulting groups in the world and has served clients for over 25 years. Over 1,500 GxP projects are completed annually with Advarra, covering every GxP area across pharma, biotech, and medical device research, including GCP, GCLP, GLP, GMP, GVP, CSV, and more.

Global Reach, Local Knowledge

With experience in over 75 countries, Advarra can help you wherever your study is based. Our auditors speak 32 languages, and each have over a decade of experience in international and local regulatory requirements.

Fit-For-Purpose Services Designed For Your Needs

Whether you are a small organization with your first product, or a large multi-national company with hundreds, Advarra is able to scale depending on your needs. Each client is assigned a dedicated project team to advise on your project — from system setup to mock inspections and anything in between.

An Extension of Your Team

For companies that need their teams to scale on-demand, you want a partner that can easily onboard while also helping to elevate quality standards. Advarra’s model for client partnerships enables us to easily assimilate into teams of all sizes and at all stages to get you up and running as quickly as possible.

Make Quality Your Competitive Advantage

Comprehensive GxP Consulting Services

Leverage Advarra’s standardized approach and unparalleled expertise across all on-site, hybrid, and remote audits, including:

Investigator site audits 
Pharmacovigilance audits 
Clinical & Specialty Laboratory audits 
Computer Systems Validation audits 
Process or system audits 
Due diligence (M&A) & Integrations 
Internal assessments/gap analysis 
Directed/for cause audits 
Good Manufacturing Practices audits 
Inspection readiness/Mock Inspections 
TMF Audits

Quality Management System (QMS) Development & Maintenance

Get expert advice on how to set up and configure your own Quality Management System. Translate industry standards for quality management systems into an agile, fit-for-purpose solution designed to scale with growing organizations. Advarra brings a flexible resourcing strategy to this process, which includes:

Systems evaluation and gap analyses for your QMS build
Developing templates, processes and SOPs to manage risk
Access to a cross-functional team of quality experts
Resource solutions for full and part time support

Process Optimization for ICH GCP E6(R3) Readiness

Make certain that all policies, procedures, and processes are updated to include new guidance and changes from ICH before they are adopted by regulatory agencies. Advarra can help:

Ensure appropriate data governance is in place
Review the security of essential records 
Embed Quality-by-Design in protocols and processes
Take a risk-based approach to quality, putting patients and critical data first
Clearly define roles and responsibilities

Inspection Preparation and Readiness

Take proactive steps by staging simulated inspections to identify and address potential issues prior to an official inspection by the FDA, EMA, etc. This can include:

Gap analyses
Mock inspections
Findings review and coaching
Situational competency training

Staffing Services for Quality Management

Advarra can help you fill in staffing gaps to help you monitor and coach your team to quality excellence.

Senior consultants
Subject matter experts (SMEs) with 10+ years of experience in quality management
Industry practitioners 
Short and/or long-term project managers

Make Quality Your Competitive Advantage

Comprehensive GxP Consulting Services

Leverage Advarra’s standardized approach and unparalleled expertise across all on-site, hybrid, and remote audits, including:

Investigator site audits 
Pharmacovigilance audits 
Clinical & Specialty Laboratory audits 
Computer Systems Validation audits 
Process or system audits 
Due diligence (M&A) & Integrations 
Internal assessments/gap analysis 
Directed/for cause audits 
Good Manufacturing Practices audits 
Inspection readiness/Mock Inspections 
TMF Audits

Quality Management System (QMS) Development & Maintenance

Systems evaluation and gap analyses for your QMS build
Developing templates, processes and SOPs to manage risk
Access to a cross-functional team of quality experts
Resource solutions for full and part time support

Process Optimization for ICH GCP E6(R3) Readiness

Make certain that all policies, procedures, and processes are updated to include new guidance and changes from ICH before they are adopted by regulatory agencies. Advarra can help:

Ensure appropriate data governance is in place
Review the security of essential records 
Embed Quality-by-Design in protocols and processes
Take a risk-based approach to quality, putting patients and critical data first
Clearly define roles and responsibilities

Inspection Preparation and Readiness

Take proactive steps by staging simulated inspections to identify and address potential issues prior to an official inspection by the FDA, EMA, etc. This can include:

Gap analyses
Mock inspections
Findings review and coaching
Situational competency training

Staffing Services for Quality Management

Advarra can help you fill in staffing gaps to help you monitor and coach your team to quality excellence.

Senior consultants
Subject matter experts (SMEs) with 10+ years of experience in quality management
Industry practitioners 
Short and/or long-term project managers

GxP Services Team

Abraham Seckler

Managing Director of GxP Services

Abraham Seckler has over two decades of experience in quality and R&D, specializing in strategically integrating quality into clinical operations while aligning with company goals. Over his career, Abraham has effectively deployed Quality strategies to best meet the needs of businesses ranging from Fortune 500 companies to startups.

Jay Westfall

Director of GCP Services

Jay Westfall brings years of healthcare industry experience to Advarra, which includes 36+ years in biomedical device and pharmaceutical industries, 30+ years of QA experience, 20+ years as an independent contract clinical and regulatory compliance auditor, and 8+ years of managerial experience. He has extensive knowledge about operational auditing, system auditing, and compliance. Westfall has conducted over 1,000 audits (GCP, GVP, GCLP, CSV) since 1994, with 100+ audits in the country of India.

Amanda Bourgeois, BS, MS, CQA

Director of GxP Services

Amanda Bourgeois is an ASQ certified CQA professional with 25 years of GxP experience in the pharmaceutical industry. She has provided operational quality leadership for pharmaceutical and biotech companies of all sizes. Bourgeois has expertise and working knowledge of quality assurance, process management, risk management and application of GMP, GCP, and GLP regulations. She has been a key contributor in several projects, including the development of SOPs, gap analyses, auditing, guidance on corrective and preventive action (CAPA) management, and overall Quality Management System/Quality Department management.

Lella Baker, BA, MDiv, CQA

Sr. Consultant of GxP Services

Lella Baker is an ASQ certified auditor with 15 years of experience working for CRO, sponsor, and post-market pharmacovigilance companies. She is experienced in audit and inspection hosting, including running backrooms, conducting training on GxP requests, and CAPA management. Baker has led GCP, GVP, TMF, and ISA audits across multiple therapeutic areas and trial phases in the US, Canada, UK, and EU.

Featured Content

Blog

GxP Audits Guide for Successful Clinical Trials

A robust GxP audit program enhances regulatory compliance by ensuring quality and consistency across investigator sites, vendors, and internal processes in clinical trials.

Blog

GxP Best Practices for Safer, Smarter, Faster Clinical Research

GxP guidelines help clinical research meet rigorous standards for safety, quality, and compliance, supporting the development of therapies and medical devices.

White Paper

GxP Compliance in Clinical Research

Explore GxP principles in clinical research, from ensuring safety and integrity to regulatory adherence, with real-world case study insights.

Blog

Good Manufacturing Practices: When Do They Apply?

Navigating cGMP application in investigational drugs can be complex. Learn how FDA guidelines help clinical teams maintain safety and quality from early trials to commercialization.

E-Book

Making Good Clinical Practice More Understandable

This eBook dives into GCP’s role in the clinical research ecosystem and how it protects participant rights, safety, and confidentiality.

Blog

ICH E6(R3) Implementation Starts Now: Are You Ready?

The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. More than a revision, E6(R3) marks a shift from traditional practices—making participant safety and data reliability not just priorities, but design drivers, and introducing risk-based proportionality as a foundational approach.

Frequently Asked Questions

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