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HIGH SUN GxP CONSULTING

GMP Consulting & GxP Compliance Services

– Focus on Pharma & Biotech –

Transparent quality · Strategic Compliance · Regulatory expertise · Operational Excellence

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Willkommen bei HIGH SUN GxP CONSULTING - GMP Consulting & GxP Compliance Services

Welcome to HIGH SUN GxP CONSULTING

GMP Consulting & GxP Compliance Services for Pharma & Biotech

We are your experts for GMP consulting and GxP compliance in the life sciences. Whether audits, QP services, validation or quality management, we provide tailored solutions for pharmaceutical and biotech companies.

Tailored Consulting for Your Quality and Compliance Needs

As a specialized consulting firm, we support you in implementing and optimizing quality management systems. Our core expertise is in GMP (Good Manufacturing Practice), complemented by experience in GCP (Good Clinical Practice) and GLP (Good Laboratory Practice). With agility, international know-how, and a strong network, we provide flexible, on-demand solutions for your needs.

Building the Future Together

Our name stands for clarity and transparency, like the sun at its zenith, leaving no shadow behind. Together, we close compliance gaps, optimize processes, and build the foundation for sustainable success in a dynamic market. Reach out to us and let us strengthen your competitiveness!

Company Profile (PDF Downloads)

Download our company profile for a concise overview of our expertise and services in GMP and GxP compliance for the life-science industry.

Company Overview (A4 Portrait)

Company Overview (A4 Landscape)

Our Services in GMP Consulting & GxP Compliance


HIGH SUN GxP CONSULTING provides tailored GMP consulting and GxP compliance services for the life science industry. With a focus on GMP, GCP, GLP and GCLP, we support pharmaceutical and biotech companies in meeting regulatory requirements and optimizing their quality management systems.

From strategic QMS design through audits and validation to operational implementation, our solutions are customized, practical and inspection-ready.

GxP Compliance Consulting – Quality management according to GMP, GCP, GLP, GCLP

GxP Compliance Consulting

Implementation and optimization of quality management systems according to GMP, GCP, GLP and GCLP.

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Interim management in Quality Assurance (QA) and Quality Control (QC)

Interim Management

Interim QA/QC support and temporary coverage as well as batch certification by a Qualified Person.

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QP Services – Batch Certification by a Qualified Person in accordance with EU-GMP

QP Services

Batch certification by a Qualified Person (QP) according to EU-GMP guidelines.

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GxP Audits & Inspection Support for Pharma and Biotech

GxP Audits & Inspection Support

Conducting internal audits and providing support during regulatory inspections.

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Consulting on regulatory affairs and GxP guidelines

Regulatory Affairs

Consulting on GxP compliance and support with regulatory submissions and approval processes.

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Project and process management in GMP environments

Project & Process Management

Planning, coordination, and implementation of complex projects in the pharmaceutical and biotech sector.

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GxP trainings and workshops for pharma and biotech

Training & Workshops

Practical and interactive on-site and remote training on GMP and GxP-related topics.

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Validation and qualification, including CSV and method transfer

Validation & Qualification

Support for validation processes, including computer system validation (CSV) and method transfers.

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Documentation and SOP preparation for GMP compliance

Documents & Documentation

Preparation and optimization of SOPs, validation plans, and reports.

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Risk management according to ICH Q9

Risk Management

Systematic risk analyses according to ICH Q9 to strengthen compliance.
 

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Change management and change controls in GMP systems

Change Management

Implementation and management of change controls and system modifications.

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Operational excellence and KPI monitoring in pharma and biotech

Operational Excellence

Process analysis, identification of efficiency opportunities, and implementation of KPI monitoring.

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About Me – Your Expert for GMP Consulting in Pharma & Biotech


I am Klaus Hajszan, founder of HIGH SUN GxP CONSULTING.

With more than 15 years of experience in senior roles within the pharmaceutical and biotech industry, I bring extensive expertise in quality and compliance management.

As a Qualified Person (QP) certified by AGES, Head of Quality Control (QC) and Quality Assurance (QA), Managing Director, as well as in my responsibilities as Test Site Manager (GLP) and Trial Facility Manager (GCP/GCLP), I have gained deep insights into regulatory requirements and the practical challenges of the industry.

My strength lies in translating complex requirements into pragmatic, efficient, and inspection-ready solutions, always with a focus on feasibility, efficiency and long-term sustainability. This way, I combine technical expertise with a solution-oriented approach that helps companies reliably achieve their compliance goals.

Portrait of Klaus Hajszan, founder of HIGH SUN GxP CONSULTING e.U., expert in GxP compliance and quality management
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Contact

We look forward to hearing from you.
Contact us for consulting or project support.
Together, we can strengthen your competitiveness!

ADDRESS

Hausbergsiedlung 30
7100 Neusiedl am See, Austria

Phone

+43 660 446 9883

E-mail

office@highsun-gxp.com

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GMP Consulting Pharma & Biotech - HIGH SUN GxP CONSULTING - Klaus Hajszan
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