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plant protection & Nutrition

→ Biostimulants

Two Pathways.
One Clear Strategy.

Since July 2022, biostimulants can be placed on the European market either through Regulation (EU) 2019/1009 or under national regulatory frameworks. Choosing the right pathway is often the first strategic decision for successful market access.
We help product owners identify the most efficient route to market, substantiate biostimulant claims and build regulatory strategies aligned with authority expectations. Our experts actively contribute to biostimulant regulatory developments, participate in standardisation activities and work closely with Notified Bodies, providing practical guidance from product development to market access

What We Deliver

  • Regulatory and market access strategy
  • FPR (EU) 2019/1009 compliance support
  • National registrations and market access assessments
  • Claim substantiation and efficacy trial support
  • Data gap analysis
  • Technical dossier preparation and submissions
  • CE marking and conformity assessment support
  • Authority and Notified Body interactions

Why It Matters

The right pathway/
The right claims/
Faster market access/

We turn complex regulatory requirements into clear decisions, helping market operators bring innovative biostimulants to market with confidence