Anadiag regulatory services
 

Regulatory Services

 
 

ANADIAG offers you a complete service for registration and development of Plant Protection Products in EU and Latin America using its long established connections with national authorities and key players. 

Our team will follow your projects from the beginning of your registrations process until the final outcome.

 
 
Plant protection products

Plant Protection Products & Bio-Pesticides
(EU Regulation (EC) N°1107/2009)

  • Specification / Equivalence Dossiers for Active Substance
  • Annex II Dossier (Active Substance)
  • Annex III Dossier (Formulation)
  • Renewal of Active Substances
  • Biological Assessment Dossiers (BAD)
  • Me-too Dossiers
  • Parallel Import Applications
  • Risk Evaluation (Operator Exposure, Environmental & Ecotoxicology risks)
  • Experimental Use Permits (EUP)
  • Second Trade name
  • Transfer of authorization
  • Extension of uses
  • Post-authorization Dossiers

 
 

Adjuvants

  • Full Dossier edition
  • Risk Evaluation: Operator Exposure, Environmental & Ecotoxicology risks (following EU Regulation (EC) N°1107/2009)
  • Biological Assessment Dossiers (BAD)
  • Renewal of authorizations

 
 

Fertilizers, Plant nutrients

Fertilizers & Plant Nutrients

  • Full Dossier edition
  • Renewal of authorizations
  • Safety characterization
  • Efficacy experimentation
  • Agronomy Dossier (nutritional benefits demonstration)

 
 

Biocides (Regulation (EU) N°528/2012)

Registration of all Biocides products (PT 1 to PT 23) as well as products of protection, general biocides, pesticides, disinfectants, etc.

 
 

Complete Customized Services

  • Assessment of the cost-effectiveness of registration investment
  • Definition of optimum registration approach
  • Expert discussion with Member State authorities

 
 

Project Management

  • Full Dossier management
  • Proactive management
  • Networking with other Experts
  • Regulatory advice to support client projects
  • Strong technical experience
  • GAP evaluation
  • Literature review
  • Dossiers re-evaluation & update to the latest EU standards