Eurofins Regulatory AG was established in 2012 and the office is based in Rheinfelden, Switzerland which is close to the Rhine and 25 km from the airport in Basel.
Offering a complete portfolio registration service, Eurofins Regulatory Ag 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 Regulatory Ag 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.
In summary, we are able to provide:
- 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
Please visit our homepage for a full description of services
Email: Vincent Dreze
Tel: +41 6183 62083
Eurofins Regulatory AG