With over a decade of experience in registration of biocidal substances and a dedicated biocides expert group, we can assist you with scientific and regulatory support for biocidal active substances and products (disinfectants, preservatives, pest control and other biocidal products). In addition, we can provide you with strategies - tailored to your product portfolio - to meet the new regulatory challenges. 

Study Conduction

The testing of biocides to generate the information required for regulatory compliance has further evolved since the entry into force of Directive 98/8/EC. In recent years more adequate study designs have to be identified to better adapt to the exposure scenarios, which are different from those for agrochemicals. GAB Consulting is keen to provide you with competent scientific support during all stages of physical-chemical, (eco-)toxicological, environmental and efficacy tests. 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 prevents unnecessary investment of your time and money.

Dossier Writing

Our expertise in the preparation of dossiers for biocides, agrochemicals, biopesticides, industrial chemicals and feed additives enables us to prepare a product dossier covering multiple categories, allowing you to market your products as widely as possible. 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

In September 2013, the new Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) came into force. This regulation requires a more stringent analysis of biocides than previously.
Our experts are fully competent in the new regulation and their expertise will ensure that you meet the new regulatory requirements. In addition to the preparation of dossiers for biocidal active substances and products, we constantly monitor the developments of the regulatory affairs assuring an exhaustive fulfilment of your obligations as a producer. In borderline cases our strong experience with active substances and related products from different categories enables us to advise you which regulatory framework is applicable and how regulatory compliance can be achieved.

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)

  • Biocidal active substance dossiers for EU approval (Dir. 98/8/EC, Reg. (EU) 528/2012)
  • Biocidal product dossiers for national / EU authorisation (Dir. 98/8/EC, Reg. (EU) 528/2012)
  • Preliminary or stand-alone risk assessments
  • Computer modelling and development of exposure scenarios
  • Expert statements
  • Literature research
  • Documentation & submission on PDF, R4BP and IUCLID files

General Consultancy & Project Management (selected services)

  • Identification and evaluation of data gaps in the data package according to current EU requirements (Check of Completeness) 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

"It is the quality that matters – a well prepared application file saves time and overall costs"

"Actions speak louder than words"