Regulatory Risk Assesment
Getting a plant protection product or biocide to market means building a complete, defensible evidence dossier. We bring the regulatory expertise, scientific depth and established relationships with competent authorities to help you do that — efficiently and with confidence.
How we help
Our regulatory consultants have worked across government, industry, contract research and regulatory consultancies — so we understand the process from every angle. Whether you need targeted advice on a data gap or end-to-end dossier support, we design the level of involvement that fits your programme and internal resources.
Data gap analysis
We review your existing data against current regulatory requirements, identify what's missing, and advise on the most efficient way to fill those gaps.
Study design and monitoring
We design studies to fill identified gaps, select and commission appropriate contract laboratories, monitor the experimental phase and review draft reports.
Dossier preparation and submission
We prepare and submit complete registration dossiers to the required standard — drawing on direct experience of what competent authorities expect.
Post-submission query handling
Registration rarely ends at submission. We support you through queries, requests for additional data and assessment authority dialogue.
Access to Fera's own laboratories
Many of the studies needed to fill data gaps can be conducted in our own GLP-accredited facilities — keeping the process streamlined and under one roof.
Global framework coverage
We've supported registrations under BPR, REACH, EU Regulation 1107/2009, EPA, JMAFF and OECD requirements — wherever you need to register, we know the route.
The right guidance at every stage of registration.
1.
Gap analysis
We assess your existing data against regulatory requirements, identify what's missing, and advise on the options — including data waiving where applicable.
2.
Study programme
We design, commission and monitor the studies you need — with access to Fera's own laboratories or a trusted network of external partners.
3.
Dossier to market
From final study reports to submission-ready dossier, we manage the process and handle regulatory dialogue through to approval.