Plant Protection

Plant protection products must comply with Regulation (EC) No. 1107/2009 before they can be placed on the market. To help you place plant protection products on the market, we offer the following services:

 

STUDY GENERATION
To place your formulation on the market you must compile a dossier for active substance and the formulated product. Both dossiers are a summary of all the studies generated. To help you with study generation we provide the following services:

    • Data gap analysis (DGA) which enables you to have a clear understanding of the costs involved in study generation and dossier preparation before you decide whether it makes sense to invest in your product or not
    • Coordination of study generation activities and advice on the service providers available
    • Advice with preparation of study summaries for your dossier(s)
    • Advice on alternative options to get access to the necessary studies in cases where generation of new studies is not advisable

 

DOSSIER PREPARATION
As soon as you have all the studies available the next step is to prepare a summary of the findings in the appropriate EU dossier format. Since we are not preparing dossiers ourselves we can support you by providing the following services:

    • Support with dossier preparation for active substances and formulated products, providing strategic advice on dossier preparation options based on the current regulatory status of the active substance in question
    • Coordination of activities and advice with dossier preparation options and service providers available

 

NATIONAL SUBMISSIONS

Once you have your dossier for your product in place, you need to prepare your dossiers(s) for submission and evaluation at the national level. Our advice is based on more than 10 years of experience and close cooperation with national authorities.

We can help you:

    • Understand different EU procedures and their data requirements in place
    • Prepare your data packages(s) in a format tailored to specific national needs.
    • Liaise with national authorities in order to facilitate discussions specific for your submission’s needs
    • Prepare complete data packages for submissions
    • Prepare individual documents in national language(s) (application forms, labels, MSDS-es, different statements, cover letters…) and facilitate communication in local language(s)
    • Handle your submissions in multiple countries simultaneously from beginning to end, with a single contact point in place for you

 

POST SUBMISSION

The success of your submissions depends very much on the activities following the submission of your application. We can offer close communications with the authorities. With the help of our expert team, we are able to answer the authorities’ questions and concerns quickly and in a professional way so that the evaluation can be facilitated and coordinated more efficiently.

Services we offer:

    • Quick and professional communication with local authorities
    • Follow up on the dossier under evaluation
    • Facilitation of communication between local authorities and applicants (and other stake holders if needed)

 

PROJECT MANAGEMENT

In cases of multiple dossier preparations for different products, and in multiple countries at the same time, your regulatory team might face capacity issues. Our team can help you by appointing a single dedicated contact person/project manager (PM) for your company who will take over all the coordination work for your ongoing registrations and take a professional, personal approach to your needs. In doing so you will only need to:

    • Send your data to one person in our team, once only
    • Communicate with one person only, who has an overview over all your ongoing submissions
    • Agree with the PM about the format and timelines of reporting according to your needs