Expertise.
CMC Consulting.
Strategic consulting for the evaluation and utilization of your CMC projects, from research to market maturity.
Unclear?
Are you lacking clear steps to drive your CMC projects forward efficiently?
Inefficient?
Are you struggling with delayed market launches or inefficient processes?
Vulnerable?
Do you lack clear approaches to minimizing risk and ensuring regulatory compliance?
Get support to make your CMC projects efficient and compliant.
CMC Consulting - Customized support for your projects.
Our CMC consulting helps you to efficiently manage projects from research to market launch.
We support you in the commercial evaluation and exploitation of your projects with customized solutions. Our approach covers the entire process from preclinical development to market readiness in compliance with the regulatory requirements of ICHQ8 and ICHQ12. We support you in optimizing your processes, preparing regulatory documents and strategic planning to make your projects more efficient and successful.
Our services include:
- Advice on commercial evaluation: analysis and planning for preclinical projects
- Process optimization: implementation of the quality-by-design approach and technological scaling
- Regulatory support: adaptation of documentation in accordance with ICHQ8/ICHQ12
Our CMC consulting solutions.
Our Chemistry, Manufacturing & Controls consultancy offers comprehensive support in every project phase.
Commercial valuation.
- Analysis and evaluation of market potential.
- Preliminary formulation and strategic planning.
- Support in the utilization of preclinical projects.
Process optimisation.
- Implementation of the Quality-By-Design approach to improve product development.
- Support with technology transfer and scale-up.
- Optimization of CMC documentation and processes.
Regulatory management.
- Adaptation of CMC documentation in accordance with ICHQ8/ICHQ12.
- Implementation of knowledge and change management processes.
- Support with regulatory review and submission.
Case Studies - Successful projects in the field of CMC Consulting.
Our case studies show how we have successfully supported CMC Consulting projects.
Commercial valuation of a biotech product
Process optimization and technology transfer for a pharmaceutical company
Adaptation of regulatory documents according to ICHQ8/ICHQ12 for an IVD company
Challenge.
An IVD company needed support in adapting its CMC documentation in line with ICHQ8 and ICHQ12 to meet regulatory requirements and accelerate market entry.Measures.
- Review and adaptation of the regulatory CMC documentation.
- Implementation of change management processes to monitor variations.
- Support with the submission of documents for admission.
Results.
- Successful adaptation of CMC documentation in accordance with ICHQ8/ICHQ12.
- Improved regulatory compliance and faster approval.
- Efficient introduction of change management processes.
Success.
The company was able to bring its products to market more quickly and fully comply with regulatory requirements.Secure strategic CMC consulting.
CMC - Optimizing your processes and ensuring regulatory compliance.
Our CMC service supports companies in efficiently meeting regulatory requirements, optimizing processes and enabling a fast, smooth market launch. Our customized consulting services cover all aspects of Chemistry, Manufacturing & Controls (CMC) and guarantee compliance with international standards and regulatory requirements.
In the area of regulatory compliance, we offer comprehensive support in the creation and adaptation of your CMC documentation to meet the requirements of ICHQ8, ICHQ10 and ICHQ12. This includes providing the necessary data for regulatory submissions as well as developing change management processes to ensure that your documentation always complies with the latest regulatory requirements. In addition, we support you in the adaptation and optimization of your CMC documentation, the creation of approval documents for national and international markets and the implementation of efficient change management systems.
Our process optimization and digitalization services aim to make your production processes more efficient and flexible through the use of advanced methods and digital tools. We implement the quality-by-design (QbD) approach to optimize product development and ensure quality during manufacturing. In addition, we support you in technology transfer between locations or partners and accompany you in process digitization to achieve efficiency increases and cost reductions. A key part of our offering is the scaling and optimization of your production processes to ensure a smooth transition from research and development to commercial production.
Effective risk management is essential to ensure the quality and safety of products and to meet regulatory requirements. We carry out comprehensive risk assessments in accordance with international standards such as ICHQ9 and implement preventive measures to identify potential weaknesses at an early stage. In addition, we offer support in preparing for regulatory audits and inspections to ensure that your processes and documentation comply with regulatory requirements. Our services also include the implementation of Corrective and Preventive Actions (CAPA) to minimize risks and ensure continuous improvement.
Well-functioning change and knowledge management is essential for long-term success. We help you to establish systems and processes that ensure that changes are implemented efficiently and knowledge is transferred seamlessly within your organization. This includes the implementation of change management systems to ensure that process changes are managed efficiently, as well as the introduction of knowledge management systems to preserve and share critical know-how. We also offer customized training and workshops to prepare your teams for regulatory challenges.
Our specialized training and courses ensure that your team is always up to date with the latest regulatory requirements. We offer training on the latest CMC requirements and workshops on process optimization and digitalization. We also prepare your employees for upcoming audits and risk management strategies to ensure that your company masters all regulatory hurdles with ease.
To future-proof your production capacities, we support you in scaling your processes and implementing continuous improvement strategies. We optimize your production processes to meet growing market demands and help you integrate new technologies efficiently. We also offer support with technology transfer from research to commercial production and the introduction of Lean and Six Sigma methods to sustainably increase the efficiency of your processes.
Secure strategic CMC consulting.
Related topics for your CMC processes.
These complementary services support various aspects of your CMC processes and help you to ensure the highest quality standards in product development and manufacturing:
