Expertise.
Good Laboratory Practice.
Optimize your laboratory processes and ensure compliance with all GLP regulations.
Efficient?
Are your laboratory processes optimized for maximum efficiency?
Secure?
Do you comply with all GLP regulations and standards?
Transparent?
Do you have clear documentation for traceability?
Optimize your laboratory processes for maximum efficiency and compliance.
GLP Consulting - Your partner for quality and efficiency.
Our Continuous Improvement Program offers you tailor-made solutions for the long-term optimization of your processes.
Our GLP consulting projects help companies to optimize their laboratory processes and meet regulatory requirements. Here are three examples that illustrate the success of our solutions.
Our services include:
- Regulatory consulting: Support in compliance with GLP guidelines such as 21 CFR Part 58, OECD, Directives 2004/09/EC, Dir 2004/10/EC and German ChemG §19a.
- Audits and assessments: Performing process, site and study audits to ensure GLP compliance.
- Training and qualification: GLP site qualification and training of your team to implement GLP requirements.
Good Laboratory Practice Services at a glance.
Our GLP Consulting Services offer you comprehensive support in the implementation, monitoring and optimization of your laboratory processes.
Regulatory security.
- Ensuring compliance with all GLP regulations and standards
- Accompaniment of audits and inspections by experts
- Preparation of the necessary documentation for regulatory compliance
Efficient processes.
- Analysis and optimization of laboratory processes for greater efficiency
- Introduction of best practices and new technologies
- Continuous process improvement and implementation of sustainable solutions
Ready for inspection.
- Preparation and monitoring of audits and inspections
- Implementation of a compliance monitoring system
- Training and workshops to ensure GLP compliance
Successful projects in the area of GLP Consulting.
Our GLP consulting projects help companies to optimize their laboratory processes and meet regulatory requirements.
Optimization of laboratory processes for a biotechnology company
Ensuring GLP compliance for a pharmaceutical company
Introduction of a GLP monitoring system for a medical technology company
Challenge.
A biotechnology company needed support in optimizing its laboratory processes to ensure GLP compliance.Measures.
- Carrying out a comprehensive audit to evaluate the existing processes
- Implementation of best practices to optimize efficiency and compliance
- Training the team to comply with GLP standards
Results.
- Improved efficiency of laboratory processes.
- Compliance with all GLP regulations
- Successful preparation for audits
Success.
The company was able to strengthen its GLP compliance and sustainably improve the efficiency of its laboratory processes.Challenge.
A pharmaceutical company needed to review its laboratory processes to ensure that they complied with GLP requirements.Measures.
- Analysis of existing laboratory processes for GLP conformity
- Conducting training courses and workshops to ensure compliance with regulatory requirements
- Preparation for upcoming audits and inspections
Results.
- Improved compliance with GLP requirements
- Increased inspection readiness and traceability
- Successful completion of inspections without complaints
Success.
The company was able to ensure the GLP conformity of its laboratory processes and successfully pass inspections.Challenge.
A medical technology company needed support with the implementation of a GLP-compliant monitoring system.Measures.
- Development and implementation of a monitoring system for GLP-compliant laboratory processes
- Training the team to use the system efficiently
- Carrying out regular reviews and adjustments
Results.
- Ensuring GLP compliance
- Improving the monitoring and traceability of laboratory processes
- Successful preparation for audits and inspections
Success.
The company was able to sustainably improve its GLP compliance and make its laboratory processes more efficient.Achieve the highest GLP standards and ensure the quality of your studies.
Our GLP Consulting Service Portfolio.
Our GLP Consulting Service offers you tailor-made solutions to ensure compliance with Good Laboratory Practice (GLP) and supports you in optimizing your laboratory processes.
Our experts provide you with comprehensive advice on compliance with GLP guidelines, including 21 CFR Part 58 of the FDA, the principles of the OECD and the specific requirements of the German Chemicals Act (§19a ChemG). We support you in the implementation of regulatory requirements and ensure that your processes comply with international standards. We can also assist you with the implementation of Good Clinical Laboratory Practice (GCLP) in accordance with EMA guidelines.
To ensure GLP compliance, we conduct comprehensive audits and assessments that check your facilities and processes for compliance with regulatory requirements. Our services include site, study and process audits as well as data integrity assessments. We also offer Source Data Verification (SDV) and Source Data Review (SDR) audits to ensure the quality of your study data. Further information on regulatory requirements can be found on the EMA website.
We offer practical training courses and qualifications to optimally prepare your team for the implementation of GLP requirements. Our training courses cover all relevant regulatory requirements, from introduction to GLP principles to preparation for regulatory inspections. In addition, we qualify sites to ensure their compliance with international standards. Details on regulatory training programs can be found at the European Commission.
To ensure that your processes comply with regulatory requirements at all times, we prepare you comprehensively for audits and inspections. We implement compliance monitoring systems and support you during official inspections, for example by the European Chemicals Agency (ECHA). Our aim is to optimally prepare you for all requirements and to successfully complete your inspections.
Our experts implement and evaluate state-of-the-art concepts such as the Benefit-Risk Action Team (BRAT) and Risk-Based Monitoring (RBM) to ensure that your monitoring strategies are up to date.
Our experts develop sustainable solutions to optimize your laboratory processes. By introducing modern technologies and implementing continuous improvement programs, we help to increase the efficiency of your processes and reduce costs. In doing so, we ensure that your processes are not only effective but also sustainable in the long term.
Ensure full compliance with GLP standards.
Good Laboratory Practice - Related topics for safe and compliant laboratory processes.
These complementary services help you to achieve the highest standards in your laboratory processes and meet regulatory requirements: