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Biotechnology Consulting.
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Biotechnology Consulting.
In biotechnology, the successful implementation of innovations is crucial in order to meet the requirements of a rapidly growing market. Our experienced consultants support you in optimizing your production processes while ensuring the highest quality standards. We help you to maximize the efficiency of your production lines while reducing costs so that you remain competitive.
Regulatory compliance, particularly in the areas of gene and cell therapy, is becoming increasingly complex. With our customized compliance strategies, we support you in meeting all regulatory requirements and securing global market access for your products. From CE marking to FDA approval - we guide you through the entire approval process.
To ensure long-term success, we support you in the introduction of new technologies and help you to integrate them seamlessly into your production processes. Our technology transfer service ensures that your innovations are efficiently transferred to production, while at the same time we carry out rigorous quality checks to ensure that your products are ready for the market.
Discover our expertise in biotechnology consulting.
Regulatory compliance & approvals.
- Comprehensive advice on CE marking, FDA approval and other global standards.
- Support throughout the entire approval process - from development to market launch.
- Support in complying with all relevant regulatory requirements and guidelines.
Process optimisation.
- Analysis and optimization of your bioprocesses to increase efficiency.
- Reduction of resource consumption and production costs.
- Introduction of lean methods to improve production processes.
Innovation management & technology transfer.
- Support with the introduction of new technologies and the market launch of innovations.
- Ensuring a seamless transfer of technology into production.
- Optimization of production processes for market-ready innovations.
Sustainability management.
- Development and implementation of sustainable production processes.
- Reducing energy consumption and waste through innovative technologies.
- Long-term strategies to achieve ecological and economic goals.
Successful consulting projects in biotechnology.
Challenge.
A biotech company needed to improve the scalability of its production processes to meet growing demands.
Measures.
- Implementation of new technologies to improve production capacities
- Optimization of resource utilization and production planning
Results.
- Increase in production capacity by 30%
- Reduction of production costs by 20%
Success.
The company was able to significantly improve its scaling processes and expand its production capacities.
Challenge.
A biotech company faced complex regulatory requirements in the development of cell and gene therapies.
Measures.
- Development of a comprehensive compliance strategy for adherence to regulations
- Advice on adapting clinical development plans to regulatory requirements
Results.
- Successful submission to the competent authorities
- Shortening the approval time by 25%
Success.
The company was able to bring its therapies to market more quickly and overcome regulatory hurdles efficiently.
Challenge.
A biotechnology company needed to make its production processes more sustainable in order to meet the expectations of investors and regulatory authorities.
Measures.
- Carrying out a comprehensive sustainability analysis
- Implementation of sustainable technologies and circular economy models
Results.
- Reduction of energy consumption by 40%
- 35% reduction in the volume of waste
Success.
The company was able to significantly improve its ecological footprint and reduce operating costs at the same time.