CONSULTING

GxP Services

Your Trusted and Proven Partner for Global GxP Quality Compliance

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

Make Quality Your Competitive Advantage

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.

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