A Complete Registration Service
Your integrated, fluid provider for trouble free solutions
Offering a complete portfolio registration service, we are your integrated provider for a cost effective and efficient service for regulatory compliance. Eurofins Agroscience Services provides a full range of services leading to the compilation of registration documentation for Agrochemicals, Biopesticides, REACH (including ORR services), Biocides and Environmental Risk Assessment for Pharmaceuticals in line with current regulatory guidelines.
Our large team of regulatory managers and product safety experts have extensive experience of negotiating with regulatory authorities, provision of regulatory advice in line with current regulatory guidelines and stewardship of dossiers through the evaluation process. We cover all of the disciplines needed to successfully compile and submit dossiers for new and existing active substances.
Eurofins Agroscience Services has the capability to advise and identify a regulatory strategy for successful registration. Undertaking data gap analysis and project management from start to finish, the group also have in-depth experience with organisation and planning of regulatory projects and dRR as well as CADDY and IUCLID dossiers. Be confident knowing that our regulatory capabilities span EU (EFSA, ECHA etc.), Rest of Europe, EPA, NAFTA, RSA, LATAM and ASEAN.
A complete registration service
In summary, regulatory services include
- Strategic Regulatory advice
- EU and EPA compliant dossier preparation for agrochemicals,Biopesticide, REACH, Biocides and Pharma (ERA)
- Writing of Biological assessment dossiers
- Risk assessments to current guidance documents
- Data gap analysis
- Proactively engaging with Regulatory Authorities at an early stage of project definition
- Proposing appropriate countries for initial submissions
- Scoping out the studies required and likely timelines to submission and market
- Project management from outset to completion
- Compilation (including dRR, CADDY or IUCLID format) and submission of the completed Dossier
- Post- evaluation Dossier stewardship and Post submission report
- All types of environmental modelling
- Toxicological and Ecotoxicological Evaluation
- Chemical Safety Reports
- ORR Services
- Participation of Member State Committee Meetings (MSCM)
- Technical Equivalence Checks
Eurofins is shaping its regulatory offering to meet new, global challenges by offering complete support to the agrochemical and chemicals industry. We have the expertise to provide a tailored strategy for the successful worldwide registration of agrochemicals, bio-pesticides, biocides and pharmaceuticals (ERA).
For further details on Regulatory Affairs, please contact Vincent Dreze