Protection & nutrition Biostimulants
RRA offers personalized support for bringing your biostimulant products to market across all European Union countries.
Since July 2022, there are two possible registration pathways for biostimulants: Regulation (EU) 2019/1009 and national regulations.
RRA can assist you in developing your regulatory strategy, preparing your national dossiers and mutual recognition applications (Regulation (EU) 2019/515), as well as preparing your European dossiers in accordance with Regulation (EU) 2019/1009.
Our offer
Strategic analysis of regulatory pathways to efficiently bring your biostimulant product to target markets
Drafting of regulatory documentation for marketing authorization applications
Support (preparation and participation) for pre-submission meetings
Monitoring of laboratory analyses
Support for setting up efficacy trials across Europe
Submission of authorization dossiers to competent authorities
Effective follow-up of the evaluation process and interaction with competent authorities
Regulatory consultancy services
Our Strengths
Our team is deeply involved in current biostimulant regulations, enabling us to provide the best support for your product approvals
- Active collaboration with notified bodies
- Close contact with national authorities
- RRA actively participated in the development of standards 17700:2024 within the European Committee for Standardization (CEN) 455, concerning the demonstration of biostimulant claims (Regulation (EU) 2019/1009)
- Regular regulatory monitoring within our team
- Continuous training of our experts
- Active participation in workshops and conferences on biostimulants
Feel free to contact our Bios’TEAM with any questions.