Expertise.
GMP consulting.
Optimize your manufacturing processes and ensure compliance with Good Manufacturing Practice (GMP).
Efficient?
Are your manufacturing processes designed for maximum efficiency and compliance?
Compliant?
Do you meet all GMP specifications and regulatory requirements?
Sustainable?
Do you have long-term strategies for optimizing your GMP processes?
Do you meet all GMP requirements and ensure efficient production processes?
GMP consulting - efficient processes and full compliance.
Our GMP consulting helps you to optimize your manufacturing processes and ensure that all relevant regulatory requirements are met.
Efficient processes and compliance with GMP guidelines are essential in pharmaceutical production. Our experts support you in analysing your production processes, identifying weak points and making targeted optimizations. We offer tailor-made solutions to ensure your GMP compliance and support you in preparing for audits.
Our services include:
- GMP process analysis: We analyze your existing production processes and identify potential for improvement to ensure compliance with GMP guidelines.
- Regulatory support: We offer advice on compliance with national and international GMP regulations and guide you through the entire audit process.
- Training and education: We offer customized GMP training for your team to ensure that all employees are familiar with the latest GMP requirements.
- Audit preparation: Our team prepares you optimally for GMP audits and supports you in preparing the necessary documentation.
Our GMP services at a glance.
Our GMP consulting services offer comprehensive support in complying with regulatory requirements and optimizing your production processes.
GMP process analysis.
- Analysis of existing processes to identify potential for improvement
- Development of measures to optimize production processes
- Introduction of digital monitoring systems for real-time compliance
Regulatory support.
- Advice on national and international GMP regulations
- Support with audit preparation and submission of documents
- Implementation of measures to ensure regulatory compliance
Training and qualifications.
- Customized GMP training for all employees
- Introduction of training programs for continuous professional development
- Qualification of personnel to ensure GMP compliance
Successful GMP projects.
Our GMP consulting has helped companies ensure compliance with regulatory requirements and optimize their manufacturing processes.
Increasing data integrity and traceability at a pharmaceutical company
Increased efficiency through GMP training at a pharmaceutical company
Optimization of compliance management for a pharmaceutical company
Challenge.
A medium-sized pharmaceutical company was faced with the challenge of implementing the new EU regulations and avoiding sanctions.
Measures.
- Carrying out a comprehensive compliance analysis to assess the new regulations
- Development of a compliance management system to comply with the new regulations
- Training the team on the new regulations and their impact
Results.
- Full implementation of the new EU regulations within six months
- Improvement of the company's documentation processes and audit capability
- Minimizing the risks of compliance violations and avoiding potential sanctions
Success.
The company was able to successfully implement the new regulations and secure its position on the European market.
Ensure your GMP compliance and optimize your operational processes.
Our Regulatory Affairs Consulting Portfolio.
Our GMP Consulting Service offers comprehensive solutions to ensure compliance with Good Manufacturing Practice (GMP) in the pharmaceutical, medical technology, biotechnology and IVD industries.
Our experts analyze your production processes, identify bottlenecks and implement measures to optimize efficiency and ensure compliance with GMP requirements. This includes reviewing documentation and adapting to international standards such as EU GMP EudraLex, ICHQ7 and 21 CFR Part 820.
We offer comprehensive support in preparing for audits and inspections by international regulatory authorities such as the FDA, EMA, ANVISA and others. Our team accompanies you throughout the entire process and ensures that all regulatory requirements according to EU GMP EudraLex, ICH Guidelines and other standards are met.
We provide customized GMP training for your team to ensure that all employees are familiar with the latest GMP and GDP requirements. In addition, we implement training systems and provide mentoring to ensure continuous compliance with standards.
Our service includes the implementation of quality systems, risk management processes and CAPA systems to ensure compliance and minimize non-conformities. We conduct regular audits and support the implementation of digital monitoring systems for real-time monitoring of production processes.
