Plant Protection Products

Meeting the requirements of the EU Plant Protection Products Regulation.

With new procedural, criteria, and data requirements, the EU Plant Protection Product Regulation is now more complex than ever. Exponent consultants have worked with many repeat, satisfied clients of all sizes, helping them with preparation and submission of active substance and product dossiers. For example, in the last two years, we have prepared 20 dossiers for active substances and more than 50 dossiers for products, including the risk assessments.

Our team of scientists has extensive experience working in a variety of regulatory disciplines with a variety of regulatory authorities, contract research organizations, agrochemical companies, and other consultancies. This multidisciplinary work has given our team an excellent mix of skills and perspectives, ensuring that our insights lead to scientific and technical information presented in the correct regulatory context.

Services

For 50+ years, we’ve thrived on solving unstructured problems that require bespoke solutions. Some of our services include:

• Dossier preparation for active substances and products, including study summaries, risk assessments, zonal dossiers, and national addenda

• Preparation of efficacy dossiers in the appropriate format

• Development of regulatory strategy and technical assistance to overcome regulatory challenges

• Classification and labeling support, including preparation of technical dossiers to support harmonized classification and labeling proposals

• Commissioning and monitoring of studies for safety and efficacy aspects of the dossier

• Preparation of literature reviews in line with EU requirements

• Preparation of dossiers for EU maximum residue levels, import tolerances, and JMPR

• Task force management for the renewal of active substances

• Preparation of documents to support comparative assessment of products

• Production and submission of dossiers in IUCLID and CADDY format

• Assessment of active substances against the various approval criteria

• Support at pre-submission meetings related to active substance approvals and product authorizations

• Full post-submission support and liaison with regulatory authorities

Our Capabilities Are Unparalleled

With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.

Experts

Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.