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 solutions include the analysis of market potential, process optimization and technology transfer. We ensure that your CMC documentation complies with regulatory requirements and that your projects can be scaled seamlessly.
Our CMC consulting solutions.
Our CMC consulting 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.
Do you need support in project, strategy or hybrid consulting?
Benefit from customized solutions for your projects in regulated industries.
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 you in meeting regulatory requirements, optimizing your processes and ensuring a smooth market launch.
- Analysis and optimization of CMC processes: Efficient evaluation and adaptation of your CMC documentation in accordance with ICHQ8/ICHQ12.
- Creation of tailor-made CMC strategies: development of processes for product development and process optimization.
- Regulatory support: Support in the preparation and submission of CMC documents for approvals.
- Change and knowledge management: Implementation of systems for monitoring process changes and variations.
- Risk management and audits: Preparation for regulatory audits and minimization of regulatory risks.
- Training and education: Further training on current regulatory changes and CMC compliance.
- Scaling and process improvement: Support for scaling production processes and technology transfer.
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