Services

We are your one-stop biomedical innovation co-development partner.

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Our success is measured by

Your success

MISSION

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.

VISION

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.

STRATEGIES

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.

Roadmap

We provide a comprehensive framework from feasibility to commercialization

Feasibility

  • 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?

Product adaptation & integration

  • 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

    • 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

      Compliance

      • 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

      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

        Office

        Biokatu 12, FinnMedi 5

        33520 Tampere

        Finland