Quality Management
From the implementation of corporate strategy through certification to optimization we ensure your entire company is positioned for the future.
We provide consulting on all aspects of quality and risk management: In line with your company’s vision, we support you in establishing new QM systems, review existing processes, and help you further develop your system. To this end we develop customized quality management systems for you, conduct training sessions and audits, and devise practical and pragmatic concepts. At the same time, we support you in overcoming your day-to-day challenges by assuming positions of responsibility, such as wholesale representatives, quality management representatives, or the person responsible for batch release.
We support you at every stage of your business, tailored to your specific needs.
Do you require help or further information?
Contact us! We are happy to advise you:
We support you in implementing and improving your quality management systems and offer customized solutions for:
- Human medicinal products
- Veterinary medicinal products
- Medical devices
- Combination products
- Primary packaging materials
- Food and nutraceutical products
- Cosmetics
- Laboratories
- Importers and distributors
- Contract manufacturers and suppliers
Plan
Human Medicinal Products
- GMP – Implementation of processes to comply with Good Manufacturing Practice
- GDP – Implementation of processes to comply with Good Distribution Practice
- GVP – Implementation of processes to comply with Good Pharmacovigilance Practice
- ICH – Implementation of ICH requirements
- AMG + AMWHV – Implementation of the German Medicines Act and the German Manufacturing Regulation for Medicinal Products
Medical Devices
- ISO 13485 Implementation for Manufacturers, Distributors, and Service Providers
- ISO 14971 Implementation – Risk Management for Manufacturers and Service Providers
- Medical Device Regulation – Implementation of MDR Requirements (2017/745)
- FDA Quality System Regulation – Implementation of 21 CFR 820 Requirements
Food
- HACCP – Hazard Analysis for Food
- ISO 22000 Implementation – Certification of the Food Safety Management System
Laboratories
- Support for ISO 17025 accreditations
- ISO 13485 for Laboratories – Laboratory Management for Medical Devices
- ISO 9001 for Laboratories – Quality Management in the Laboratory
- Support for GMP Certification for Laboratories
Importers and Distributors
- Implementation of GMP Requirements for Pharmaceutical Distributors
- Implementation of GDP Requirements for Pharmaceutical Distributors
- Implementation of the MDR for Distributors and Importers of Medical Devices
- Quality Management for Distributors – Support for ISO
- 9001 Certification
- ISO 13485 for Distributors of Medical Devices
Veterinary Medicinal Products
- GMP – Good Manufacturing Practice for veterinary products
- GDP – Good Distribution Practice for veterinary products
- GVP – Good Distribution Practice for veterinary products
- ICH – Implementation of ICH Requirements for Veterinary Medicines
- TAMG – Implementation of the Veterinary Medicines Act
- AMWHV – Implementation of the German regulation on manufacturing of medicines for veterinary medicines
Combination Products
- GxP – Implementation of Requirements for Combining Medicines and Medical Devices
- ICH – Implementation of ICH Requirements
- MDR – Implementation of Requirements for Combinations of Medical Devices and Medicinal Products
- ISO 13485 – Implementation for Manufacturers and Contract Manufacturers
- ISO 14971 – Implementation for Manufacturers and Contract Manufacturers
- FDA Quality System Regulation – Implementation of 21 CFR 820 Requirements
Cosmetic Products
- ISO 22716 Implementation – Quality Management for Cosmetics
- Cosmetics GMP – Implementation of Cosmetics Regulation 1223/2009
Primary Packaging Materials
- ISO 15378 Implementation – Support for ISO 15378 Certification
- ISO 9001 – Quality Management for Packaging Materials
Contract Manufacturers and Suppliers
- Establishment and Support of an ISO 9001 QMS
- Implementation of ISO 13485 for Contract Manufacturers of Medical Devices
- Implementation of ISO 22716 for Contract Manufacturers of Cosmetic Products
- Implementation of the MDR for Contract Manufacturers and Service Providers of Medical Devices
- Implementation of GMP Requirements for Service Providers of Medicinal Products
- Implementation of GDP requirements for pharmaceutical service providers
- Implementation of GVP requirements for pharmaceutical service providers
- Implementation of cosmetic GMP requirements for contract manufacturers of cosmetic products
Do
We’re happy to support you in managing your processes during times of limited resources and major challenges.
Feel free to entrust your responsibilities to us.
During the execution of your processes
- Risk Management
- Internal Audits and Supplier Audits
- Validations
- Regulatory Activities
- Process Management
- Training
- Trending
- Stability Analysis
- Vigilance
- Deviations, CAPAs, Change Controls
- Product Quality Review
- Compliance Check
- etc.
By assuming positions of responsibility
- We provide support as an external Responsible Person for Wholesale Distribution (VP)
- We act as an external Qualified Person (QP)
- Quality Management Representative (QMB) – We support you as an external QMB
- Responsible Person for Medical Devices (PRRC) – We support you as an external PRRC
- We support you as an external Graduated Plan Officer (GPO or "Stufenplanbeauftragter" in Germany)
- We support you as an external Information Officer (IO)
- Qualified Person for Pharmacovigilance – We support you as an external QPPV
- External Responsible Person for Controlled Substances – We support you as an external BtMV
- We take over external management of quality control for you
- We take over external management of manufacturing for you
We support you as an external risk manager - We offer support with supplier audits as an external second-party auditor
- We support you as an external validation engineer
- etc.
Check
We help you identify areas for improvement to further develop your business.
- Review of processes for implementing the corporate strategy
- Analysis of your key performance indicators and goals for implementing the corporate strategy
- Review of existing processes to incorporate new requirements
- Review of your administrative and operational processes to identify areas for improvement
- We offer support in improving your processes
- Efficient processes — we offer support for your process optimization
- We help you achieve greater effectiveness and flexibility
- Consistency as the cornerstone of your quality management system. We help you design consistent processes and optimize interfaces
Act
Quality management for greater efficiency and agility throughout the entire value chain. Customized and agile solutions for an effective and efficient quality management system: We help you identify areas for improvement and implement the right tools and methods to boost your efficiency.
Process Management
- Designing lean processes
- Improving interfaces
- Customer focus as the central orientation of processes
- Monitoring and measurement for control and improvement
- Focus on business objectives
Agility
- Identifying opportunities for improvement
- Implementing agile methods
- Implementing flexible processes—support for an agile
- quality management system
Risk Management
- Identifying business risks
- Risk-based definition of processes to reduce business risks
- Risk-based approach in accordance with ISO 13485
- Risk management in accordance with MDR, ISO 14971, and ISO 9001
- Quality risk management in accordance with ICH Q9
- Identification of risks and opportunities in accordance with ISO 9001
- Risk-based monitoring of your suppliers
Integrated Management Systems
- Linking your management systems for efficient implementation
- Integrating new regulatory requirements into existing QM systems
- Consolidating processes and documents to create a clear and structured QMS
Waste Prevention
- Methods for identifying waste throughout the entire value chain
- Solutions for eliminating waste
- 5S in production
- 5S in administration
Quality Planning
- Risk-Based Planning of Quality Controls
- Development of Inspection Plans for Your Products
- Statistical Control of Products and Processes
- Structured Handling of Nonconformities
- Development of Control Plans for Your Incoming Goods Inspections
Digitalization
- Improving the Efficiency of the QM System Through Digitalization
- Support in Identifying Suitable Software Solutions
- Support in Adapting Existing Processes for Digitalization
- Support in Software Validation According to ISO 80002 or GAMP 5
- AI in Production. Support in Managing AI-Driven Production Processes
Sustainability
- Reducing waste
- Monitoring REACH requirements
- Monitoring and implementing PFAS requirements
- Support in tracking your suppliers