Efficacy

Our experts prepare Biological Assessment Dossiers (BADs) and the efficacy part of the technical documentation for biostimulants. This includes data management by using ARM and monitoring of efficacy trials in any country.

We are here to help!

Find out how we can support you specifically in the efficacy assessment of your product

What can we do for you?

Data Analysis

  • data gap analysis
  • check of compliance with regulatory requirements
  • preliminary assessment
  • cost estimation

Dossier Preparation

  • zonal and national submission
  • complete BADs or single chapters
  • technical documentation for biostimulants according to Regulation (EU) 2019/1009

Comparative Assesment

  • assessments of products containing “candidates for substitution”

Dossier Support

  • authority requests
  • expert statements
  • synthetic and biological products

Study Monitoring

  • large network of experienced laboratories
  • quotation gathering
  • close monitoring of studies
  • revision of study designs and reports
  • notification

Study Reports and ARM ST

  • statistical analysis and summary of test data
  • data management

We look forward to hearing from you!

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