We, as a consulting house in the pharmaceutical industry, have placed our focus on the topic of medicinal cannabis. We support companies in this demanding market, starting with the planning of state-of-the-art greenhouses and production buildings, right through to the distribution of the finished cannabis medicines.
Our goal is to implement the highest pharmaceutical quality standards and to develop high-quality cannabis medicinal products with you.
GMP
- Design of processes in the segment of product substance according to specific GMP guidelines
- Development and preparation of specifications
- Setup of a GMP organisation incl. implementation and establishment of QM processes
- Qualification and validation
GACP
- Design of processes in the segment of drug substance according to specific GACP guidelines
- Support for business plan preparation
- Development and preparation of specifications
- Setup of a GACP organisation incl. implementation and establishment of QM processes
Research & Development
- GMP-based processes in the area of research and development
- Selection of analysis methods (incl. supplier selection)
- Setup of a laboratory structure for analytics
- Establishment of analysis methods
- Online measurement methods
- Evaluation and statistics based on analysis
- Method validation
- Qualification and validation
Our Services
We support you with training and advice during the whole process so that the audits and all processes can be conducted through staff after the project is finished.
Gap-Analysis
- Conducting gap audits to determine the current GxP level in terms of product, process, documentation, equipment and buildings.
- Uncovering compliance deviations and optimisation potentials
- Preparation of a gap report and development of action plans and time schedules to close identified gaps
- Support in the implementation of measures, e.g. with a view to upcoming audits by the authorities or optimisation of economic efficiency
Quality Management
- Development of high-level documents (Site Master File, Validation Master Plan, Business Plan) and the necessary basic documentation (technology/process/quality management).
- Training and coaching of responsible personnel according to current ICH guidelines for all relevant processes and systems, both initially and for periodic refresher training
- Creation of a digital document twin to optimise and simplify the structure and data management thanks to a strong partnership with SIEMENS
- Creation of qualifications, validations and risk analyses
Design of the Production Site
- Support in the planning of GxP-compliant production facilities for medicinal cannabis products according to the quality-by-design approach
- Optimisation of material and personnel flow paths
- Advice on the hygienic design of cultivation and processing rooms
- Creation of concepts for the best possible use of available resources
Product and Process Development
- Project management and implementation for all stages (development up to implementation of the GACP/EU GMP/GDP concept)
- Development of product specifications for different dosage forms of medicinal cannabis
- Establishment of manufacturing processes for cannabis products in pharmaceutical quality and support of these with customised software solutions
- Establishment of analytical methods according to applicable testing standards and pharmacopoeias
- Establishing business goals and strategies for a company in the health sector
Supplier Management
- Development, establishment and implementation of a supplier management process
- Planning and implementation of supplier audits
- We can be your link between different EU-GMP compliant suppliers from the pharmaceutical industry or the European Cannabis Association (ECA) through our large network.
Regulatory advice
- EU-GMP support
- Advice on questions of national and European pharmaceutical law
- Technical and regulatory support in the implementation of GxP requirements
- Legal advice through cooperation with DENTONS
Continuous Partnership
- Long-term cooperation with suppliers and companies from the pharmaceutical industry as a guarantee for high quality of the optimised processes established by us.
- Regularly carrying out audits to maintain the high quality status
- Establishing and maintaining contact with the responsible authorities in order to provide quick solutions to any problems that may arise
- Even after completion of a current project, we are happy to stand firmly by your side to ensure continued excellent product quality according to the highest standards
