Redebel Regulatory Affairs SRL
RRA manages the approvals and/or renewals of bio-sourced active substances as well as the registrations of plant protection products containing them in Europe (following Regulation (EC) 1107/2009) and beyond. We assist our clients with data gap analysis, strategy determination, study monitoring, dossier preparation, risk assessment and finally submission for microorganisms and botanicals. RRA also ensures optimal follow-up of the evaluation process through our strong network among EU and Member States authorities.
Biostimulant and fertilizer
RRA offers strategic analysis for fertilizers and biostimulants registration under Regulation (EU) 2019/1009 or national rules of the 27 Member States. We assist clients with pre-application stewardship, drafting technical files, monitoring lab analyses, setting up efficacy trials, submitting registration dossiers, and interacting with authorities throughout the evaluation process.
