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.
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 the largest GxP consulting group 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 Expertise
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 partnership enables us to easily assimilate into teams of all sizes and at all stages to get you up and running as quickly as possible.
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 over 46 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 professional with 25 years of pharmaceutical GXP quality experience, including 8 years of project management. She has worked with contract manufacturers, contract laboratories, small startup pharmaceutical developers and currently, a GxP QA consulting firm. Bourgeois is a GMP subject matter expert with knowledge of various drug forms (vaccines/biologics/solid dose/API), as well as GLP, GCP, Quality Management Systems, and auditing across GxPs.
Lella Baker, BA, MDiv, CQA
Sr. Consultant of GxP Services
Lella Baker is an ASQ certified professional with 25 years of pharmaceutical GXP quality experience including 8 years of project management. She has worked with contract manufacturers, contract laboratories, small startup pharmaceutical developers and currently at a GXP QA consulting firm. Baker is a GMP subject matter expert with knowledge of various drug forms (vaccines/biologics/solid dose/API), as well as GLP, GCP, Quality Management Systems, and auditing vendors across GXPs.
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Frequently Asked Questions
Explore our comprehensive FAQ page for detailed answers to questions about our IRB, IBC, DMC, and EAC services.