Huomio

Sivustoa ei ole optimoitu vanhentuneelle selaimellesi.

Explorer Päivitä Internet Explorer selaimesi uusimpaan versioon tästä .

Tai kokeile näitä ilmaisia selaimia:

Chrome Google Chrome tai Firefox Mozilla Firefox

Case Examples

  • RD CASE

    Repolar

    New product in markets

    For Repolar Ltd, we applied for public funding, and acted as project manager in their research and development project. We planned the studies together with Repolar, tendered and evaluated the best contract research organizations and made sure that the project met it’s goals in time and within the given budget.

    View Case Repolar

  • QA Case

    Blueprint Genetics

    Blueprint Genetics is Finnish start-up company that provides clinical gene testing and customized next-generation sequencing services. Effective Quality Management System is crucial for Blueprint Genetics as the company targets to very tightly regulated EU and US markets.

    Kasve helped Blueprint Genetics to plan the QMS structure in compliance with international ISO 15189 standard and the USCMS CLIARegulations (42CFR493). Kasve participatedinall parts of the QMS build-up project, which was executed in extremely tight schedule.After QMS build-up, Kasve continues as an outsourced Quality Manager of BlueprintGenetics.In April 2015, Blueprint Genetics was CLIA-certified by the US CMS, and ISO 15189 accreditation process by FINAS is ongoing.

    “Kasve has been our external expert in the very wide QMS building project. Without Kasve’s help it would have been impossible to achieve our goal in very challenging time schedule”.

    Samuel Myllykangas, Chief Technology Officer, Blueprint Genetics

  • QA Case

    Repolar

    Upgrade in quality level resulted ISO 13485-certification.

    Repolar’s products are medical devices in the class 2b. During 2013-2014 Kasve planned and managed a substantial upgrading project for Repolar’s Quality Management System. Project resulted an ISO 13485-certificate issued for Repolar by Notified Body. Kasve also acts as an outsourced Quality Manager for Repolar Ltd.

    View Case Repolar

  • BD Case

    Akeso Pharmaceutical

    Akeso Pharmaceutical is a Russian pharmaceutical company. With its strategic partners Akeso provides Russian market with wide range of healthcare products. Kasve helps Akeso in business development between Europe and Russia.

    Kasve has been acting as Akeso Pharmaceuticals´ european business development partner since 2014. Kasve scouts and evaluates the most potential european products to be marketed and distributed by Akeso within the Russian Federation. Kasve currently leads the distribution agreement negotiations for Akeso. Kasve works together with Akeso after product launch in ensuring that the business is feasible for both Akeso and the product manufacturer.

    ”I am very glad that I have had the opportunity to get acquainted with Kasve. We have already signed the first agreements, which shows the quality and efficacy of Kasve´s work. I can trust business development to such attentive and professional company, which gives prompt answers to any questions.”

    Mr Imran Mir, Managing DirectorAkeso Pharmaceuticals

    Kasve has been acting as Akeso Pharmaceuticals´ european business development partner since 2014. Kasve scouts and evaluates the most potential european products to be marketed and distributed by Akeso within the Russian Federation. Kasve currently leads the distribution agreement negotiations for Akeso. Kasve works together with Akeso after product launch in ensuring that the business is feasible for both Akeso and the product manufacturer.

  • BD Case

    Repolar

    New market areas in focus

    Kasve evaluated the market potential of Repolar’s product in Russia and India. Kasve searched and contacted potential marketing and distribution partners, presented products to professional users in institutions and hospitals and made registration preparations. The negotiations with the potential marketing and distribution partners are currently on-going.

    View Case Repolar