Strategic Planning & Execution
By stepping back from the day-to-day, we help you understand complex situations in context and make sound strategic decisions. Our services combine practical experience with structured thinking – from transformation to market entry and scale-up.
Focused Strategic Support for the Pharmaceutical Industry
Are you re-evaluating your operational structure, preparing for expansion, or facing a critical decision point in your pharmaceutical value chain?
At GxPerts, we understand that no two companies – and no two moments – are alike. That’s why we work closely with you to define strategic pathways that are not only sound in theory but also resilient in practice.
We don’t offer textbook solutions. Instead, we bring hands-on experience from decades in pharma, biotech and chemical manufacturing to help you align internal realities with regulatory and market expectations. Let’s move beyond buzzwords and define what real progress looks like in your context.
How can our planning experts support your next strategic step?
Strategic Services in Pharma Operations
We support pharmaceutical and biotech companies in addressing strategic and operational challenges in complex, regulated environments. With a structured, solution-oriented approach, we help you make well-informed decisions and implement change effectively.
Strategic Execution & Change Enablement
We support pharma and biotech companies in translating strategic intent into operational reality. From restructuring programs to organizational growth initiatives, our experts help defining clear goals, aligning stakeholders, and navigating change with resilience and clarity.
Supply Chain Design & Resilience
Our strategic supply chain services ensure your material flow and sourcing structures are built to withstand global uncertainty. We advise on make-or-buy decisions, risk mitigation and supplier diversification strategies tailored to your product portfolio.
Manufacturing Scale-Up & CMO Oversight
We provide guidance during scale-up and commercialization by supporting the selection, qualification and oversight of CMOs. Our expertise includes high-potency APIs and drug products, ensuring your partners meet both technical and regulatory expectations.
GMP Facility Planning & Engineering Advisory
From initial design to GMP-compliant realization, we help planning pharmaceutical production and R&D facilities. Using structured methods like the User Brief, we ensure operational and quality goals are built into your CapEx project from day one.
Decision Support & Operational Due Diligence
When strategic decisions depend on technical realities, we provide structured assessments to reduce risk. Whether for M&A activities, site selection or product transfers, our due diligence combines commercial, operational and regulatory expertise.
Martin Schneider
CEO & Founder of GxPerts
Dedicated to your success
in GxP for over 25 years
Hands-On
operational Excellence
Direct involvement in Quality Assurance, including FvP roles, with adeptness in managing Quality Systems, Control, Analytics, and ESH. Combining hands-on expertise with managerial excellence in Regulatory Affairs and CSV for comprehensive operational success.
Qualified Auditor for all
international GxP standards
Auditing experience in Europe, China, India Korea and Taiwan.
Strong Service
Mentality
Experience for CMOs and CDMOs in GXP environment, for Drug Products, Drug Substances and Cosmetics.
Compliance Remediation
Strategist
Developed the strategy for and lead the remediation activities after a statement of non-compliance or a warning letter
International Compliance
Success
Proven success in preparing and managing manufacturing sites for global authority inspections, including SwissMedic, FDA, EMA, EDQM, PMDA, MFDS, ANVISA and others.
Versatile Client Portfolio
With extensive GxP experience, we serve a diverse range of clients cross pharmaceuticals, biotechnology, and cosmetics industries, while maintaining strict confidentiality.
“In our experience, navigating strategic or technical complexity is easiest when we talk directly.”
Send me a message!
Ready to elevate your compliance and operational excellence? Reach out today to discuss how we can achieve your GxP goals together!