HIGH SUN GxP CONSULTING
GMP Consulting & GxP Compliance Services
– Our Services in Detail –
Consulting portfolio for Pharma & Biotech – from compliance strategy to operational excellence
Our Services
GxP Compliance Consulting
Our GxP compliance consulting supports pharmaceutical and biotech companies in implementing and optimizing quality management systems (QMS) in line with international standards such as GMP, GLP, GCP, and ISO 17025.
Our Services include:
- Analysis and implementation of complex regulatory requirements (AGES, EMA, US-FDA)
- Establishing sustainable compliance structures through gap analyses and inspection support
- QA and QC systems for both start-ups and established companies
- Consulting for mergers and reorganizations with a focus on essential quality processes
- Development of control and communication systems for initial and repeat inspections (AGES, EMA, US-FDA)
- Design, implementation, and qualification of laboratory infrastructures
Interim Management
With our interim management services, you gain temporary expertise in pharma and biotech to quickly and efficiently close leadership gaps. We take on key roles in GMP- and GxP-regulated areas, ensuring the stability of your quality processes.
Our Services include:
- Temporary filling of leadership positions (Head of QA/QC, Qualified Person)
- Crisis management by an experienced GxP task force
- Acting as Test Site Manager, Trial Facility Manager, or Study Director as needed
- Support in stabilizing quality processes after reorganizations
- Development of transition plans for the implementation of sustainable solutions
- Coordination of interdisciplinary teams within pharmaceutical companies
- Training and mentoring of employees during transition periods
QP Services
Our QP services ensure GMP-compliant batch release in accordance with §7 AMBO. As a Qualified Person (QP), we assume responsibility on an interim, project-based, or long-term basis, supporting pharmaceutical and biotech companies in meeting all regulatory requirements.
Our Services include:
- Acting as Qualified Person for batch certification under EU-GMP
- Interim or project-based assignments as QP
- Support with internal audits and mock audits, including CAPA management
- Conducting external QP audits for suppliers and business partners
- Preparation of certificates and reports for regulatory purposes
- Expert consulting on QP responsibilities under EU-GMP guidelines
- Assistance in preparing for regulatory inspections
GxP Audits, Inspection Support & Supplier Qualification
With our expertise in GxP audits, we support pharmaceutical and biotech companies in preparing for, conducting, and following up on inspections in line with international standards (EMA, AGES/BASG, US-FDA). Our goal is to ensure compliance while making your audit processes more efficient.
Our Services include:
- Preparation for regulatory inspections (EMA, AGES/BASG, US-FDA)
- Internal audits to ensure GMP, GLP, and GCP compliance
- Supplier audits for the qualification of external partners
- Specialized audits of GLP facilities with a focus on regulatory requirements
- Support in audit and inspection management, including CAPA activities
- Development of audit schemes aligned with international standards (e.g., ICH guidelines)
- Consulting to optimize audit processes and improve efficiency
Regulatory Affairs & Operating Licenses
Our regulatory affairs consulting helps pharmaceutical and biotech companies ensure compliance with national and international requirements. From obtaining operating licenses to preparing for inspections, we make sure your processes meet current GxP standards.
Our Services include:
- Consulting on GxP guidelines (GMP, GCP, GLP, GDP) and international regulations
- Support with applications and extensions for operating licenses
- Preparation for regulatory audits and inspections (EMA, US-FDA, and others)
- Development of strategies to adapt to new regulatory requirements
- Consulting on pharmaceutical approval processes and related documentation obligations
- Support with the harmonization of quality standards in multinational projects
- Preparation of risk management plans in line with ICH Q9
Project & Process Management
We support pharmaceutical and biotech companies in managing complex projects and processes efficiently. Our approach combines regulatory expertise with modern methods such as Lean and Six Sigma to achieve measurable results that bring compliance and business performance into alignment.
Our Services include:
- Managing and coordinating complex projects from planning through implementation
- Developing and implementing efficient process structures in line with regulatory requirements
- Applying Lean and Six Sigma methodologies to optimize processes and increase efficiency
- Harmonizing processes across departments and sites
- Introducing project management tools and KPI systems for transparency and traceability
- Supporting change projects with a focus on quality, compliance, and sustainability
- Coaching and mentoring project teams to ensure the long-term integration of best practices
Training & Workshops
Our training and workshop programs support pharmaceutical and biotech companies in building and strengthening competencies in quality and compliance management. We combine regulatory expertise with practical, hands-on methods to ensure lasting learning outcomes.
Our Services include:
- On-site and remote training on GMP, GCP, GLP, and GCLP
- Development of technical and leadership skills in quality management
- Customized training plans for employees in pharma and biotech
- Practical SOP training and reviews
- Support with certifications for regulatory functions
- Workshops on audit preparation and compliance strategies
- Integration of e-learning modules to ensure continuous professional development
Validation & Qualification
Our validation and qualification services support pharmaceutical and biotech companies in meeting GMP guidelines and international standards. We accompany projects from planning through documentation, ensuring that systems, equipment, and methods are fully compliant with regulatory requirements.
Our Services include:
- Consulting on facility and process validation in accordance with GMP
- Support with equipment qualification
- Assistance with computerized system validation (CSV) under GAMP 5
- Development and validation of analytical methods in line with GLP, GCLP, and GMP requirements
- Method transfers between sites or companies
- Preparation of validation plans and reports for regulatory purposes
- Qualification of cleanrooms and manufacturing environments
- Implementation of validation management systems
Documents & Documentation
Structured and compliant documentation is the foundation of every GMP compliance system. We support pharmaceutical and biotech companies in developing, maintaining, and optimizing documentation systems. These may be paper, hybrid, or fully electronic solutions.
Our Services include:
- Drafting, reviewing, and optimizing SOPs, work instructions, and Site Master Files
- Implementing, training, and maintaining quality management documentation systems
- Developing validation plans and reports to meet regulatory requirements
- Harmonizing documentation processes across multinational organizations
- Consulting on migration to electronic documentation systems
- Preparing audit trail documentation to ensure GxP compliance
- Employee training on the proper handling of documentation systems
Risk Management
Effective risk management is essential for regulatory compliance and economic stability. We support pharmaceutical and biotech companies in implementing and optimizing risk management processes in accordance with ICH Q9 and international GxP standards.
Our Services include:
- Implementing and optimizing risk management processes in line with ICH Q9
- Conducting comprehensive risk analyses using appropriate tools such as FMEA, HACCP, and Ishikawa to identify critical process risks
- Developing and documenting risk management plans for GMP, GLP, and GCP environments
- Integrating risk management into QMS and CAPA processes
- Supporting regulatory inspections related to risk management
- Training in risk management methods and their practical application
- Establishing early warning systems and KPIs to proactively manage quality and production risks
Change Management
Effective change management is essential to ensure that changes in regulated environments are implemented safely and in compliance with GMP and GxP requirements. We support pharmaceutical and biotech companies in planning, managing, and documenting change processes.
Our Services include:
- Management support during transformations, mergers, and reorganizations
- Expert guidance for critical GxP events, including root cause analysis and CAPA development
- Consulting on adapting quality processes to new regulatory requirements
- Communication with authorities during change control processes
- Designing change management plans for international projects
- Conducting team training to ensure smooth transitions
- Performing change impact assessments to minimize risks
Operational Excellence
With our operational excellence approach, we increase the efficiency and quality of processes in pharmaceutical and biotech companies. By applying Lean methods, KPI monitoring, and continuous improvement programs, we create sustainable competitive advantages in GxP-regulated environments.
Our Services include:
- Increasing efficiency through Lean methods and KPI monitoring in pharmaceutical processes
- Optimizing the value chain in the biotech and pharmaceutical industries
- Introducing continuous improvement programs (CIP)
- Reducing production waste through targeted process optimization
- Implementing performance management systems to strengthen quality control
- Consulting on automation of routine processes in GxP environments
- Training teams to ensure the sustainable adoption of operational excellence strategies
