Thé road to registration


Efficacy and Composing BAD (Biological Assessment Dossier)

Linge Agroconsultancy has long experience in the field of efficacy. Linge Agroconsultancy is a evaluator for the Dutch Board for the Authorisation of Plant Protection Products and Biocides (Ctgb). We can assist you in the entire process, from trial protocol to dossier. Through regular meetings with the Ctgb and by attending relevant workshops (such as given by EPPO), we keep informed of the Dutch and European policies.
We have experience with both chemical and microbial plant protection products for authorization in Europe.

Some of our services:

-    Required research
We can advise you on the number and type of trials required for authorization. In the advice possibilities of extrapolation, bridging and minor uses are taken into account. We can advise on the required testing for new registrations, label extensions of label changes.

-    Trial protocols
We can advise you on trial design and trial protocols, when for instance EPPO guidelines appear impracticable. We can put you into contact with officially recognised testing facilities or communicate with them on your behalf.

-    Trial visits
We can visit trials and analyse and discuss preliminary results or problems that arise during the trial.

-    Completeness check
We check the available data for completeness in line with the European guidances and take possible national specific elements into account. Where additional data is required we advise on the number and type of trials that are to be conducted. 

-    Biological Assessment Dossier (BAD)
Using trial protocols we compose a Biological Assessment Dossier in your desired format, for instance the OECD format, adapted dRR format or the format of your organisation.

-    Draft Registration Report (dRR)
Using the BAD we compose a Core Assessment and/or National Addendum in line with the dRR template. In the dRR we evaluate the available data in line with the European requirements and potential national specific elements.

-    Resistance Risk Analysis
We can provide a resistance risk analysis according to EPPO, using provided data or literature.

-    Comparative Assessment
For products that contain an active substance listed as a Candidate for Substitution, a comparative assessment must be submitted for new registrations, renewals or label extensions. The comparative assessment is evaluated on a national level. 

-    Literature study
In certain cases it is possible to use scientific literature and thereby reduce the number of required trials. In a literature study we analyse and summarize the relevant literature.

-    Questions authorities

We can provide argumentation or answers to questions or requests for additional data from authorities.

Contact: Oosterhoutsestraat 95, 6678 PG Oosterhout (NL). Phone: +31 (0)481-745045
E-mail us

Registration Process
Registration dossier
Efficacy / BAD
Data-gap analysis
Risk Assessment / Modelling
Literature Study
MRL application

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