Industries.
Biotechnology Consulting.
Our specialized biotechnology consulting services provide you with targeted support in the development, approval and marketing of your innovative products.
Complex?
We guide you safely through regulatory requirements, especially for gene and cell therapies and ATMPs.
Regulated?
Our experts ensure compliance with local and global regulations for fast and smooth approvals.
Innovative?
We optimize your processes and support the efficient transfer of technology from research to scalable production.
Accelerate your biotech projects with us!
Biotechnology Consulting - Driving innovation, optimizing processes.
Our specialized biotechnology consulting services help you to successfully implement innovative biotechnology projects and reliably meet regulatory requirements.
We provide you with comprehensive support in the development and market approval of complex cell and gene therapies (advanced therapy medicinal products, ATMPs), biopharmaceuticals and sustainable biotechnological processes. Our experts provide you with targeted support in complying with the regulatory requirements of the EMA and FDA as well as relevant quality standards such as ISO 20387.
We sustainably increase your productivity through targeted process optimization and efficient technology transfer from research to production. We help you to minimize regulatory risks, maximize product quality and secure your innovative strength on the market in the long term.
Benefit from our experience and comprehensive industry expertise to implement your biotechnology projects efficiently, competitively and in compliance with regulations.
Our focus in biotechnology consulting.
Our biotechnology consulting services offer you comprehensive support in bringing innovative technologies to market and overcoming regulatory hurdles.
Regulatory compliance & approvals.
- Advice on Advanced Therapy Medicinal Products (ATMPs) according to the EMA
- Support with biological approvals according to FDA regulations
- Quality management for biotechnology companies according to ISO 20387
- Preparation of approval dossiers for cell and gene therapies, biopharmaceuticals and genetically engineered products
- Support with interactions with authorities and strategic market approval
Process optimization & production management.
- Scaling biotechnological production processes to increase efficiency and capacity
- Introduction of lean biomanufacturing principles to reduce costs
- Optimization of bioreactor technologies for higher cell and protein yields
- Automation and digitalization of upstream and downstream processes
- Sustainability strategies to reduce energy consumption and waste generation
Innovation management & technology transfer.
- Development of technology transfer strategies for new biotechnological processes
- Support with the introduction of new production platforms (e.g. single-use technologies)
- Implementation of circular economy models for bio-based production
- Regulatory-compliant validation of new laboratory technologies and manufacturing processes
- Advice on the market launch of innovative biopharmaceutical products
Discover our Life Sciences expertise.
Research and Development and Engineering
We support your product development with innovative solutions for design, validation and implementation.
Clinical and Medical Affairs
We offer comprehensive expertise in study management, risk assessment and market surveillance.
Quality Management and Operational Excellence
We optimize your processes to increase efficiency and ensure the highest quality standards.
Business Data Solutions & IT Services
We create sustainable strategies and optimize your IT processes for maximum efficiency.
Manufacturing and Supply Chain Management
We develop solutions for efficient production and smooth supply chains.
Regulatory and Compliance
We navigate you safely through complex regulatory requirements and audits.
Successful consulting projects in biotechnology.
Our case studies illustrate how we have helped companies in the biotechnology sector to optimize their production processes, overcome regulatory hurdles and successfully implement sustainable innovations.
Optimizing scalability in bioproduction for a growing start-up
Overcoming regulatory challenges in cell and gene therapy development
Integration of sustainability into the biotechnology processes of an international pharmaceutical company
Challenge.
A global pharmaceutical company with a biotechnology division 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.
- 40% reduction in energy consumption through the integration of sustainable technologies
- 35% reduction in waste generation through circular economy models
Success.
The company was able to significantly improve its ecological footprint and reduce operating costs at the same time.
Meet all regulatory requirements.
Our Biotechnology Consulting Services.
Our comprehensive consulting services provide you with holistic support - from the development of innovative technologies and regulatory approvals to the efficient scaling of your biotechnological production.
Our experts provide you with comprehensive support for the approval of genetic engineering and biotechnology products, including complex gene and cell therapies (ATMPs). We guide you through the entire regulatory process with international authorities such as the EMA and FDA, provide support with CE marking and ensure that your products meet all relevant international requirements. By identifying regulatory risks at an early stage, we ensure fast approvals and minimize regulatory delays.
We help you to make your biotechnological processes more efficient by systematically analyzing, optimizing and validating your production processes. Our consultants implement continuous improvement measures and lean principles to increase your production capacities and sustainably reduce operating costs. In doing so, we take into account current requirements and quality standards such as ISO 20387 for biotechnological processes.
The development of Advanced Therapy Medicinal Products (ATMPs) requires innovative strategies and detailed knowledge of regulatory requirements. We develop customized development and approval strategies for you in accordance with the EMA guidelines for Advanced Therapy Medicinal Products (ATMPs) and the corresponding FDA requirements for gene and cell therapies in order to bring your innovative therapies to market safely and on time.
Our service provides you with comprehensive support for the technology transfer of your innovations from the laboratory to industrial production. We support you in the validation of new processes, production facilities and technologies. Our consultants ensure smooth transfers and strict process validation in accordance with international quality requirements so that your biotechnological innovations are ready for production quickly and safely.
Sustainability is becoming increasingly important in biotechnology. We support you in the introduction of sustainable production processes, optimize your energy consumption and develop waste management strategies in accordance with international sustainability standards. Responsible production processes improve your ecological performance and at the same time increase your attractiveness to investors and regulatory authorities.
Get to know our experts.
Get in touch with our experts from the biotech industry.
Dr. Nils Sunder-Plassmann
Head of Pharma
Andreas Weirich
Head of Pharma Sales
Patrizia Piscopiello
Principal Consultant
