FAKKEL bvba

About FAKKEL bvba

FAKKEL offers support during the product development life cycle to put it onto the market. 2DEVELOP We help TO DEVELOP a Quality System (ISO 9001 or ISO 13485). In the pre-clinical phase, we help you with implementation of the biological assessment (ISO 10993) and other applicable ISO-standards and wraps the results in a submission dossier ready for regulatory review. 2PROVE We help you TO PROVE the value of your product during the FIM/POC clinical phase. Our efficiency and engagement in defining and implementing clinical trials makes us YOUR PREFERRED PARTNER. 2IMPROVE Your organization is growing and you have excellent people who want TO IMPROVE their performance: they need guidance and training that we can offer. Your organization needs acute strong, strategic leadership or you want to implement some changes to improve the efficiency of your organization? FAKKEL offers the interim manager needed TO IMPROVE the functioning of your group and to offer more quality in shorter time periods for less money. 2EXCEL Our site management skills assure a fast start up of the clinical trial. Patient recruitment is often a big bottle neck: unraveling the problem and boosting the rate is our specialty. For sponsors, non-compliant data are a nightmare: we provide adequate coaching to hospital staff through which you can save time and money! We help you TO EXCEL your trial and to make the sponsor-clinical site investigator relation become a true PREFERRED PARTNERSHIP!

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