With 15 years of experience in registration of pesticides, our expertise spans from providing you with up-to-date information on your regulatory obligations and evaluation of data gaps to the preparation and submission of complete dossiers for active substance and product approval according to Regulation (EC) No 1107/2009 and in compliance with national regulations.

 

 

Study Conduction

The testing of agrochemicals is carried out according to the latest guidelines to generate the information required for regulatory compliance under Regulation (EC) No 1107/2009.

We are keen to provide you with competent scientific support during all stages of physical-chemical, (eco-)toxicological and environmental tests as well as efficacy and residue trials. We are in contact with the best laboratories and research institutions who will conduct studies using the most up-to-date guidance and accurate techniques. Together with them we also develop suitable designs for complex experimental problems and produce high quality reports which prevent unnecessary investment of your time and money.

Dossier Writing

GAB Consulting prepares your dossiers under the European standard regulations and OECD Guidelines for dossier compilation, which enables you to use your data packages also under North American and Japanese standards.  Multiple dossiers can be prepared at the same time considering specific data requirements according to different EU and overseas regulations.
This strategy reduces workload and therefore the cost for the dossier compilation. 

 

Our One-Stop Service concept provides our clients with high-quality regulatory services. Clients may choose the services that meet their specific needs best – in packages or stand-alone.

Regulatory Aspects

We provide the full range of services related to the registration of agrochemicals  in the EU following the criterion set out by Regulation (EC) No 1107/2009 (which repealed and replaced Council Directive 91/414/EEC). Adjuvants, safeners and synergists also fall under this regulation.  Approved active substances are listed in Regulation (EU) No 540/2011.

In addition to the preparation of dossiers for agrochemical active substances and products, we constantly monitor the developments of the regulatory affairs assuring an exhaustive fulfilment of your obligations.

Follow-up Activities & Dossier Defence (selected services)

  • Review and commenting of authorities‘ assessments on EU and national level
  • Risk refinements
  • Expert discussions and negotiations with authorities

Dossier Preparation (selected services)

  • Annex II / Annex III Dossiers in OECD format /Annex III in dRR format for zonal registration and in accordance with Regulation (EC) No 1107/2009 for EU and in compliance with national regulations
  • Preliminary or stand-alone risk assessments
  • Computer modelling and development of exposure scenarios
  • Specific summaries for different levels (e.g. Tier I, Tier II)
  • Expert statements
  • Literature research
  • Documentation & submission on CDs, PDF-files and CADDY

Project Coordination / General Consulting (selected services)

  • Identification and evaluation of data gaps in the data package according to current EU requirements (Check of Completeness) for agrochemicals and preliminary risk assessments
    (human & environmental exposure, risk characterisation human health & environment)
  • Cost analysis for completion of the data package (including statements) and preparation of a registration dossier
  • Time schedule for study conduction and dossier preparation
  • Support in the selection of contract laboratories,
    contracting of studies
  • Scientific support and study monitoring

"Expertise and creativity in addressing data requirements is decisive for registration success"

"The satisfaction of a job well done"