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Regulatory plan Celluminova

Reference number
Coordinator Celluminova AB
Funding from Vinnova SEK 88 200
Project duration February 2017 - September 2017
Status Completed
Venture Medtech4Health: Competence Enhancement in SME

Purpose and goal

The company’s goal is to develop tools to improve survival rates and life quality for patients with glioblastoma. The purpose of the project was to assure correct classification of the product, as required before development of a regulatory strategy and plan. The goal was reached; it is beyond doubt that the product is classified as a drug. The regulatory plan has been initiated. Furthermore, several products based on the same compound have been identified to strengthen the company business case. Clinical experts and business competences have been approached.

Expected effects and result

In discussion with clinicians and researchers, current directives and regulatory barriers / opportunities were identified. Possible preclinical and in vitro diagnostic products were identified, with relatively good market potential and of major strategic significance. Development plan and regulatory strategy were developed with these included. We have received very strong positive feedback from experts in clinical and preclinical research, as well as business development, and now form a highly competent board.

Planned approach and implementation

The project plan was that the CEO would work very closly with the experts from SICS East, through physical meetings and telephone / e-mail. The cooperation has proceeded as planned and worked very well. As well the CEO as the experts have individually and together met a large number of external experts. Communication has worked well within the group.

External links

The project description has been provided by the project members themselves and the text has not been looked at by our editors.

Last updated 25 November 2019

Reference number 2016-05209

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