
Bridging the Gap: Unparalleled GMP Compliance from Both Sides of the Audit Table.
Navigating Global GMP with the Insight of an Audited Expert and a Seasoned Auditor.
“I help pharmaceutical, biotechnology, and medical device companies to master complex GMP compliance and confidently navigate stringent regulatory and client audits, so they can accelerate market access, mitigate risks, and embed a sustainable culture of quality. My unique advantage stems from decades of firsthand experience as both a GMP Officer/Auditee facing diverse international authorities (including FDA, EU, African, Chinese, Russian, and Turkish regulators) and as a Lead/Co-Auditor across Canada, India, France, Switzerland, and Germany, providing a holistic understanding of challenges and pragmatic solutions.”
Have unexpected GMP findings surfaced during an audit?
Do you need immediate support to fix compliance gaps?
Struggling with outdated documentation, deviation management, or digital GMP systems?
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I don’t just offer advice — I deliver real, practical solutions.
You’re not buying hours — you’re investing in outcomes.
With over 30 years of international GMP experience and Swiss precision, I turn compliance challenges into success stories — quickly, efficiently, and sustainably.
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Unlike larger consulting firms that often pass projects from one available consultant to another, I personally manage every project from start to finish. I accept only one project at a time — dedicating 100% of my focus, energy, and expertise to delivering the best possible outcome for you. No divided attention. No compromises. When you work with me, you get true commitment and results you can trust.
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Unlike many consultants who rely solely on theory, I bring over 30 years of hands-on GMP experience to every project.
From microbiological quality control laboratories to leading quality management teams, from implementing deviation and CAPA systems to conducting international audits — I have worked across Switzerland, Germany, France, India, and Canada.
Throughout my career, I have built, optimized, and stabilized compliance systems for pharmaceutical and life science companies of all sizes.
There is hardly a GMP challenge I have not seen — and solved.
When you work with me, you benefit from real-world expertise — not guesswork. -
PIn regulated industries, precision is not optional — it is essential.
With a Swiss-trained mindset for detail and compliance, I bring meticulous accuracy to every project, from documentation structures to audit preparation.
Whether writing SOPs, optimizing deviation systems, or building quality frameworks, I ensure every step is aligned with current regulations and best practices.
Precision protects your company — and I make it a core part of every solution I deliver.
Swiss quality. Global expertise. GMP solutions made for you.
About Schmidt GMP-Compliance
With over 30 years of experience in the GMP-regulated pharmaceutical and life science industry, I offer premium consulting services tailored to your compliance needs. As a certified Senior GMP Consultant, Quality Manager, and experienced Third-Party Auditor, I've successfully implemented and managed Quality Management Systems (QMS) across international markets, including Switzerland, Germany, France, India, and Canada.
My Comprehensive GMP Solutions
At Schmidt GMP-Compliance, I offer a full range of services designed to meet your every compliance need. From the development of essential GMP documentation—including SOPs, Site Master Files, and robust CAPA systems—to thorough risk analyses, equipment qualifications, and critical independent third-party audits, I cover every detail.
My deep expertise extends to digital solutions, ensuring your operations are not just compliant, but also efficient and future-ready. I specialize in Laboratory Information Management Systems (LIMS), Enterprise Resource Planning (ERP) systems, and advanced digital deviation and CAPA management tools. Through these services, I consistently deliver Swiss precision, unwavering reliability, and pragmatic compliance solutions that truly work.
My Promise to You
For complete peace of mind, I primarily offer transparent flat-rate pricing to give you full cost control – ensuring no hidden fees or unwelcome surprises.
Beyond fixed pricing, I continually align my consulting services with the latest industry developments and evolving GMP regulations to ensure you always stay one step ahead in compliance.
Tailored GMP Solutions — Transparent and Reliable.
Explore a selection of service packages designed to deliver results with Swiss precision and a commitment to your success.
CHF 990
Flatrate
CHF 9.800
plus travel-costs
CHF 4.900
Flatrate
CHF 1.800
Flatrate incl. travel-costs
Why Work With Me?
Personalized Compliance Solutions Backed by Global Experience
With over 30 years of hands-on GMP experience, I bring the precision and dedication that regulated industries demand.
Unlike larger consulting firms, where projects are often passed from one consultant to another, I personally handle every assignment — from first briefing to final audit report.
One consultant. One focus. One result: your compliance success.
What Sets Me Apart
Unmatched Focus — I accept only one project at a time. This guarantees full attention, deep engagement, and faster, audit-ready results.
Cross-Industry Expertise — Pharmaceuticals, medical devices, cosmetics, and logistics (GDP) — I understand the unique challenges of each sector.
Swiss-Made Precision — Every process, every document, and every audit plan reflects Swiss standards for quality, detail, and reliability.
Global Reach, Local Understanding — Audits and compliance projects across Europe, North America, and Asia — always adapted to your regulatory environment.
Actionable Compliance Solutions — No templates, no theoretical advice. Every recommendation is practical, implementable, and designed to pass real-world inspections.
Book Your Appointment — Fast, Secure, Reliable
How It Works:
Select the service that fits your needs.
Pick a time from the real-time availability.
Book instantly — no waiting for confirmation.
Receive an immediate confirmation email with all details.
Reschedule or cancel easily up to 24 hours before the appointment if needed.
Our Promise:
✅ Real-time availability — no hidden delays.
✅ Immediate confirmation — secure your spot in minutes.
✅ Flexible rescheduling — easy and stress-free.
✅ Global expertise — Swiss precision, worldwide compliance.
Need Help?
For any questions about booking, rescheduling, or services, feel free to contact me at: 📧 info@schmidt-gmp.com
Get in Touch — Let’s Talk Compliance
Do you have questions about my services, want to schedule a consultation, or need immediate GMP support? I'm here to help.
Simply fill out the form below or reach out directly via email or phone. I respond personally and promptly to every inquiry, ensuring you get the focused attention you deserve.