Strategic and regulatory consultancy
We help businesses turn compliance into a competitive advantage through tailored strategies and expert guidance.
Regulatory consultancy
Supporting passionate innovators in a timely and cost-effective manner to navigate complex regulations, contribute to more sustainable agriculture and ensure safe food for all.
Our regulatory experts and project managers provide strategic advice for the success of your registration dossiers.
Regulatory support does not necessarily stop at the point of dossier submission. Liaison with regulators can continue throughout the evaluation and life-cycle-management of active ingredients and/or formulations.
With extensive experience in the various regulatory arenas, our teams have worked under a range of partnership models over their many years of active operation.
Our expertise includes:
- Physico-chemistry and analytical methods
- Toxicology
- Residue and metabolism
- Environmental fate, behaviour and environmental modelling
- Ecotoxicology (aquatic and terrestrial)
- Environmental risk assessment
- Efficacy
- Environmental risk assessment for human pharmaceuticals and veterinary medicine
- Endocrine disruption
The Eurofins Agroscience Regulatory team is constantly expanding its capacity and capabilities across the globe and can call upon an network of expert partners for those regions not covered in-house.
Our services
- Analysis of business objectives and proposition of cost / time-efficient regulatory strategies for both actives and formulated products
- Regulatory due diligence and overall regulatory strategy development
- Development of successful strategies for non-submission of data (e.g. read-across approaches)
- Collaboration with in-house laboratory and field services to deliver tailor-made solutions for non-standard testing conditions and other complex regulatory challenges
Project management
Our project management solution is your trouble-free route to managing complex regulatory projects.
- Advise on regulatory strategies, solutions to scientific problems and interpretation of results in the context of registration requirements for your crop protection, biopesticide or biocide products
- The most relevant team of technically competent specialists from global in house resources or selected partners
- Managing and controling budget, ensuring financial aspects of the project are appropriately managed
- Facilitating swift communication and easy flow of information across multiple locations, study types, standards and concepts both in-house as well as with subcontractors
- Delivering in accordance with your timelines and ensure objectives and time scales are met
- Projects will be coordinated in line with your needs
Coordination, preparation and submission of your registration dossiers
From preparation to final submission, we ensure your dossiers meet regulatory standards — on time and with precision.
- Project management
- Data gap analysis
- Risk-assessments (from preliminary to higher-tier)
- Expert statements
- GLP and GEP Study monitoring
- Classification and labelling (CLP)
- Dossier writing (OECD and IUCLID formats)
Discussions with competent authorities (from dossiers pre- to post-submission)
Our experts can represent your interests at every stage — pre-submission, review, and post-submission — providing clarity, compliance, and confidence throughout the process.
- Request and conduct pre‑ and post-submission meetings
- Coordinate responses as follow-up of the meetings including generation of any potential supplementary data
- Track submission status and maintain updates
Life-cycle management of actives and/or formulations
From development to post-approval, we ensure your products remain compliant, competitive, and future-ready.
- Track regulatory changes
- Adjust regulatory strategy design
- Plan for data generation
- Provide support in portfolio optimisation
Task forces & consortia management
We coordinate multi-stakeholder collaborations to achieve regulatory and strategic goals efficiently.
- Identify stakeholders
- Establish governance structure
- Develop joint regulatory strategy
- Coordinate study programmes
- Secure systems for exchanging sensitive information
- Ensure consistency and regulatory acceptability of shared data
- Joint representation to authorities
- Respond to regulatory queries collectively
- Manage confidentiality and transparency obligations
- Regular periodic reviews
Regulatory surveillance
We monitor evolving regulations to keep your business compliant and competitive — before changes impact you.
- Track evolving regulations at EU, national, and global levels (e.g., EFSA, EPA, OECD)
- Monitor guidance updates on data requirements, risk assessment methodologies, and submission formats
- Identify upcoming legislative changes (e.g., hazard classification, endocrine disruptor criteria, sustainability initiatives)
- Scan scientific opinions and technical reports that may influence regulatory decisions
- Analyse regulatory trends to anticipate implications for active substances and formulation
- Provide feedback during public consultations on draft regulations or guidance
- Monitor the latest regulatory advances through our participation in several industry working-groups
- Publication of a free monthly regulatory newsletter (link to the registration page)
Regulatory trainings
We develop training programmes tailored to clients’ unique needs.
- Training programmes tailored to customers’ unique needs
- Courses led by our Section Leaders and Principal
- On-site workshops, virtual sessions, or blended approach
- Accommodate schedules and learning preferences
- Beyond training sessions, ongoing support and resources to help you stay updated with the latest regulatory changes and best practices
Remote regulatory consulting services
We provide you with a dedicated project manager for a timebound period, depending on your needs.
- Integration: Project Manager working as part of the client's team
- Communication: Use of the client's communication tools to ensure smooth collaboration.
- Flexibility: Tailored to the client's needs, e.g. temporary replacement of expertise during medical leave, maternity leave, etc., or any other customised arrangements
- Confidentiality, security and ethics: Separate computer systems and strict adherence to the client's data security protocols. Guaranteed ethical behaviour in all aspects, including contracting for studies and other consultancy projects
Regulatory resources
Legislation on Plant Protection Products (PPPs) Regulation EC 1107/2009
Our senior Regulatory Project Managers look at EU regulatory support approaches for microbials
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH): (EC) No 1907/2006
Classification and labelling of chemicals (CLP): Regulation (EC) 1272/2008
Take a look at our brochure for more detailed information on specific services.