GXP Consulting – GXP Consulting

GLP, GCP, GMP and GPV Compliance Experts

GLP, GCP, GMP and GPV Compliance Experts

Meet our GXP team

The GXP Compliance Experts.

We have never failed a BiMO or PAI inspection and we have remediated many failed BiMOs and PAI’s ectors for over a decade

About GXP Consulting

GXP CONSULTING a Global Consulting firm has established a reputation for providing the highest standards of compliance expertise in GLP, GCP, GMP and GPV to small and mid sized pharmaceutical and biopharmaceutical firms

GXP Team

GXP Consulting has a growing team of full-time permanent consultants, each with an average QA experience of over 15 years, based across the globe. We have many former regulators and inspectors in our organisation, who can quickly and effectively help you mitigate GxP compliance risks and manage any remedial activity you are involved with.

Are you a Small Startup

If you are a small start-up who lacks the financing to hire a full complement of GXP( GLP, GCP and GMP) professionals to implement Phase appropriate quality systems, perform the required compliance oversight of your clinical programs, then our seasoned GXP Consultants can help.

GXP Consulting Services We are a Global Consulting firm based in San Francisco who can work seamlessly to provide compliance solutions for established and emerging, small and mid-sized Biopharmaceutical and Pharmaceutical firms throughout the globe. We offer the following services

Quality Management Systems(QMS) Implementation

We have over 100+ combined years of consulting with our experienced consultants who have vast experience in developing and maintaining quality systems that is phase appropriate for our clients.

GCP QA Expertise

Our auditors has an average of 15 years GCP QA experience and has conducted thousands of audits in all therapeutic areas, according to international and national regulations, in over 100 countries.

Auditing Services

Audits of clinical investigators sites, Testing Laboratories, pharmacovigilance audits, 21 CFR Part 11Computer Systems Validation (CSV) audits

GXP Compliance Oversight

Prepare and execute Audit study plans for all Phases of a Clinical Trial (I-V). Provide Compliance Oversight throughout your clinical program lifecycle “From Concept to Commercialisation ™ (Phase 1-4)

Good Laboratory Practice (GLP)

Our GLP auditors has the experience and capability to conduct audits of all types including: facilities; process data; study specific data and reports against GLP requirements.

Inspection Readiness

We have over 100+ combined years of consulting with our experienced consultants and have been operating for over a decade on the global market.

Technical Writing

We can draft and implement SOPs for all aspects of your clinical program, we can review validation protocols and reports, annual product reviews, FDA correspondence, audit responses, strategic plans, and other technical reports.

Remediation Activities

We provide remediation work plans and system redesign to address FDA Consent Decrees, warning letters, 483s

Data Integrity

We provide directed audits and analysis of clinical sites to assess and data integrity concerns and fraudulent practices.

More than 100 Years
of Combined Experience

25+ Consultants Employed

100+ Satisfied
Customers

GXP Consulting Mile Stones

GXP Consulting has been operating in the Pharmaceutical and biopharmaceutical sectors for over a decade. Our core competency is compliance and we are known as The GXP Compliance Experts. We have never failed a BiMO or PAI inspection and we have remediated many failed BiMOs and PAI’s and also biennial inspections to address 483’s, Warning Letters and Consent Decrees.

2010

GXP Consulting began working with sponsors to remediate FDA 483 actions, Warning Letters and Consent Decrees. Provide GXP auditing expertise to sponsors prepare and host BiMOs and PAIs
2012

GXP Consulting began working with Sponsors to prepare for and host successful BiMOs and PAIs
2015

GXP Consulting provides extensive GXP Compliance Oversight to sponsor firms from Concept to Commercialisation
2022

GXP Consulting is known as the GCP Compliance Experts in the Biotech industry

Contacts

Global Headquarters : San Francisco, CA , USA
(888) 899-0614
gxpconsulting@clinprotrials.com