Vision Statement
To be the most trusted partner for GMP excellence worldwide empowering life science
companies to turn compliance into competitive advantage.
Mission Statement
Achieving and Sustaining GMP Compliance
At Truex Consultancy, we help life sciences companies achieve and sustain GMP compliance. Through expert-led audits, training, and quality system solutions, we ensure operational integrity, regulatory readiness, long-term success, and patient safety.
Navigating Complex GMP Requirements
We specialize in helping life sciences companies navigate the complexities of Good Manufacturing Practice (GMP) compliance with confidence and clarity. We have been a trusted partner for pharmaceutical, biotech, and healthcare manufacturers looking to build robust, inspection-ready quality systems.
Hands-On Industry Expertise
Our team brings deep industry knowledge and hands-on experience in regulatory audits, validation, documentation, training, and quality system design. Whether you’re preparing for an inspection, facing data integrity challenges, or building a facility from the ground up, we tailor our solutions to your unique operational needs.
Our Practical and Collaborative Approach
We believe compliance should be practical, risk-based, and aligned with quality principles. Through close collaboration with your internal teams, we strengthen quality culture, reduce non-conformities, and foster continuous improvement. This ensures your organization stays ahead of global regulatory expectations.
Our clients span sectors
Pharmaceutical manufacturing
Biotech and advanced therapies
Medical devices
We take pride in being more than just consultants we’re problem-solvers, trainers, and long-
term partners in your compliance journey.
Our objectives
Quality and Compliance Leadership
Establish a reputation for delivering comprehensive solutions that ensure full adherence to
evolving regulatory requirements.
Broaden Market Engagement
Expand the organization’s footprint by entering new regulated territories through strategic
certification acquisition and partnership development within the upcoming year.
Establish Strong Client Satisfaction and Retention
Build a foundation of high client satisfaction by delivering projects on time, maintaining
transparent communication, and providing customized compliance solutions that foster
lasting partnerships
GMP Compliance Self-Assessment
Our services
Provision of highly qualified interim professionals to bridge staffing gaps in GMP/GDP environments
Quality Risk Management (QRM)
Solve Complex GMP & Regulatory Challenges
Develop Long-Term GMP Compliance & Growth Strategies
Drive Operational & Quality Excellence
Project Management
Contact us
Truex Consultancy brings specialized GMP compliance consulting and GDP expertise tailored to your unique challenges.
We’re ready to support your next regulatory milestone, operational transformation, or
strategic shift. Whether you need shortterm guidance or longterm partnership Truex
Consultancy is ready to help.
Connect with our experts to navigate regulatory and development complexities with
confidence and drive success across your entire GMP/GDP journey.
Blog
GMP Deviation Management: Requirements, Common Failures, and What Inspectors Actually Find
What EU GMP, ICH Q10 and 21 CFR actually require for deviation handling, the eight places deviation systems fail in practice, and what inspectors look for when they open your deviation log.
GMP Audit Preparation: Why QA Departments Scramble, and How to Build Continuous Inspection Readiness
By Gregory Sivo | Truex Consultancy | Updated May 2026 | 12-minute read GMP audit preparation has a way of turning into a last-minute scramble. This article explains why that happens, what the scramble reveals about the underlying quality system, and how...
GMP Change Control: Requirements, Common Failures, and What Inspectors Actually Find
By Gregory Sivo | Truex Consultancy | Updated May 2026 | 12-minute read Learn what EU GMP and ICH Q10 require from a change control system, why change control programmes fail in practice, and what a compliant, inspection-ready process looks like from the inside. One...
GMP Compliance Self-Assessment
Fifteen questions, one for each regulation the FDA cited more than once in July 2026. Those fifteen provisions of 21 CFR 211 account for 55 of the month's 75 observations. Answer honestly. The score is for you, and nobody sees your answers unless you choose to share them. When you finish you can download the full analysis of all 62 inspections classified that month.
Before You Go,
Check Your GMP Compliance Status with Our Free Audit Checklist!