We are your one-stop biomedical innovation co-development partner.
To bring internationalization directly into the development phase.
Life sciences is an international field that has a heavily regulated development environment that creates unique requirements for human factors and user needs in cross-cultural and cross-national design to ensure patient safety across borders.
We combine the regulatory and R&D landscape from Switzerland, Japan and China into a unique set of know-how where east meets west to enhance the internationalization of innovations.
We provide access to advanced, reliable and up-to-date knowledge on how to run a development process that is internationalizing from an idea to commercialization.
Implementing internationalization directly into the development process will create an effective market entry strategy and provide access to new knowledge and innovations.
Integrating requirements for regulations and commercialization into the development process will make the business more agile.
- Multidisciplinary analyses
Feasibility studies aim to give a comprehensive perspective on the following questions:
- Are there equivalent innovations on the market?
- What optimization routes are implementable?
- Intellectual Property (IP) and patent filing?
- Which markets are targeted? Why? When? How?
Considering the questions above:
- Which regulations have to be met?
- Are clinical trials needed?
- Idea formation and conceptualization
- Optimization and molding plan for alignment
- Alignment of a technology, product or application to a new product
- Identification of specifications
- Risk management framework and planning
- Risk analysis and assessments
- Controlling and minimizing the risks
- Documentation and reporting of risk management
Verification and validation
- Planning and development of verification testing
- Planning and development of validation testing
- Documentation and reports
- Ensuring compliance with regulations
- Managing regulations for planning monitoring
- Managing the monitoring process for planning
- Compliance with international standards (EU regulation, FDA regulation)
- Know-how of the local regulations and standards in Switzerland, Germany, Japan and China
From feasibility to verification & validation all actions should aim for:
- Demonstration of patient safety
Commercialization via internationalization should be integrated into the development process as early on as possible.
- Commercialization strategies
- Business economics
- Business models
- Market entry strategies
- Partnerships & alliances