Advice on
regulatory affairs

Liaison with the
French Authorities

Technical and regulatory
training courses

Outsourcing
GLP / GEP studies

Preparing technical
and adminsitrative
dossiers

Approval
of plant protection
products

Three types of offer

Turnkey service

Monitoring your product mix,
Handling all regulatory matters.

Project management service

Preparing dossiers, from identification
of the requisite studies to submission.

Custom services

Providing answers to regulatory questions
and carrying out ad hoc assignments.

Our regulatory services

Advice on plant protection products regulations

  • Regulatory and strategic advice
  • Data gap analysis
  • Preliminary risk assessments
  • Development of budget estimates and retro-planning

Monitoring of GLP studies and GEP field trials

  • Study / Field trial programmes
  • Choice of CROs
  • Protocols review and, if necessary, adaptation to product specificities
  • Studies follow-up
  • Laboratory / Trial visit
  • Study reports review

Drafting of administrative dossiers

  • Label extension dossiers for minor and major uses
  • Mutual Recognition Dossiers
  • Bis Product Dossiers
  • Applications for second name, resale…

Follow-up with Authorities

  • Submission of dossiers
  • Liaison with the French Authorities
  • Answer to the supplementary data requests
  • Post-approval follow-up
  • Partnership with local consultants (Southern and Central zones)

Other services

  • Drafting of labels and SDS (classification and labelling)
  • Translation English/French, French/English

Drafting of technical dossiers

  • Preparation of dossiers for new product or renewal (dRR – zonal dossiers and National addenda)
  • Literature search (EFSA, 2011)
  • Drafting of statements to justify data waiving
  • Phys-chem and method of analysis expertise
  • Human Health risk assessment (EFSA, 2014 and national models)
  • Consumer risk assessment (PRIMo and national models)
  • E-fate calculations:
    • PECsoil (2014 and 2015 EFSA guidance)
    • FOCUS GW/SW
    • FROGS (French Refinement Of Groundwater Scenarios)
    • and other National modelling
  • Flora and fauna risk assessments
    (Tier I and higher Tiers, National risk mitigation measures)

    • Birds / Mammals (EFSA 2009)
    • Water-dwelling and sediment-dwelling organisms
    • Bees (Apis mellifera, Bombus spp. and solitary bees)
    • Non-target arthropods (ESCORT 2, 3)
    • Non-target plants
  • Adaptation and development of exposure models
    (intended uses not covered by standard models)
  • Preparation of Biological Assessment Dossiers (BAD)
    (zonal or National)

    • Selection of valid field trials
    • Compilation of data (ARM or Excel sheets)
    • Resistance risk management
    • Reasoned statements and conclusions