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BIOMARKER REGULATORY QUALIFICATION

We help our clients to optimize each step of their biomarker research and development programs, from concept to regulatory qualification for all international markets.

Our team has significant experience in the regulatory qualification of biomarker-based panels and in vitro diagnostics (IVD) tools in Europe (development and submission for CE marked kits) and in the US (IVD and LTD kits) according to EMA and FDA guidelines.

Use our expertise in analytics, regulatory strategy, and in biospecimens solutions for comprehensive support across your research needs:

 

  • Design of biomarker program and analytical development
  • Planning and study design
  • Development of Standard Operating Procedures (SOPs)
  • Regulatory support: preparing dossiers and opinion meeting
  • Biomarker regulatory qualification for IVD development

 

Contact us now to get further details about Firalis Consultancy Service and to discuss your projects.

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Firalis Group

© Copyright 2020 all rights reserved. 

The company logos, products and service marks are trademarks or registered trademarks of Firalis.

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Information addressed to health professionals. The products presented on this site are for professional use only and, where applicable, comply with the requirements of the IVD Directive 98/79 / EC. Instructions for use must be consulted before using these products.

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Headquarter : 17 Rue du Fort 68330 Huningue FRANCE

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