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Regulatory affairs support for biocides, plant protection products and REACH, in Europe and internationally, from dossier strategy to submission and exchanges with authorities.
Where we take the mandate, we also work on cosmetics, medical devices, human medicines and other regulated products.
Our core scope
Our core scope
Three frameworks make up most of our work. Each has its own page with the full list of services. We can also prepare registration dossiers for the United States and other markets when a project needs it.
Biocides (BPR)
Biocides (BPR)
Active substance and biocidal product dossiers, from first strategy to authorisation.
Dossier preparation and data gap analyses
IUCLID dossiers and R4BP applications
Poison centre notifications and UFI generation
Efficacy testing: laboratory, simulated-use and field
Endocrine disruption assessments
Plant protection products (PPP)
Plant protection products (PPP)
Approval and authorisation support under Regulation (EC) No 1107/2009 and other national frameworks, including plant growth regulators.
Dossier preparation and data gap analyses
Risk assessment and modelling: environmental fate, ecotoxicology, metabolites and residues
Efficacy trials and laboratory studies, GLP and non-GLP, coordinated and monitored
Applications and exchanges with authorities
Endocrine disruption assessments
REACH and CLP
REACH and CLP
Registration and compliance for substances, including Letters of Access where data must be shared.
Registration dossiers in IUCLID
Data gap analyses
Classification and labelling (CLP) and SCIP notifications
Task forces and consortia: set-up and management
Exchanges with authorities
Work that runs across every mandate
Work that runs across every mandate
Dossier strategy
Procedure and country options, applicable guidance and authority fees, set out as written decision points.
Data gap analyses
What the framework requires, what your data package already covers, and how to close the gaps.
Letters of Access, data sharing, other regulatory documents
Data ownership, access letters and data-sharing agreements, prepared and signed in AlexSignum, our document workspace.
Exchanges with authorities
Applications, submissions and follow-up questions, prepared for you as the applicant.
Study and dossier monitoring
Laboratory and field studies, GLP and non-GLP, followed from protocol to final report.
Risk assessment
Human health, environment, endocrine disruption and combined exposure.
Searches and document revision
Literature and database searches, and revision of documents and dossiers before submission.
Statistical analyses
Statistical evaluation of study data in a regulatory context.
Beyond the core, on mandate
Beyond the core, on mandate
Where we take the mandate, we also work on cosmetics, medical devices, human medicines and other regulated products, such as toys, feed additives, food supplements and fertilising products. The method stays the same: technical file, data review, assessment and exchanges with authorities.
Specialist services
Specialist services
Risk assessment and modelling
Exposure scenarios and modelling for workers, consumers, bystanders, animals and the environment, including endocrine disruption and combined risk assessment.
Studies and testing
Efficacy testing for PT18 and PT19 products, from laboratory to field. Toxicology, ecotoxicology and physical-chemical studies with our partner laboratory, Edara Research Foundation (ERF), in Hyderabad, India.
On-site training
Regulatory affairs training at your site, built around your team: dossier preparation and submission, risk assessment, and regulatory updates including New Approach Methodologies (NAMs). In Europe, and elsewhere on request.
Frameworks we work under
Frameworks we work under
Core
Core
Biocidal Products Regulation (EU) No 528/2012
Plant Protection Products Regulation (EC) No 1107/2009
REACH Regulation (EC) No 1907/2006
CLP Regulation (EC) No 1272/2008
Examples, not a complete list.
Other frameworks and markets:
Other frameworks and markets:
Cosmetic Products Regulation (EC) No 1223/2009
Medical Devices Regulation (EU) 2017/745
Medicinal products for human use Regulation (EC) No 726/2004
Toy Safety Regulation (EU) 2025/2509
Feed Additives Regulation (EC) No 1831/2003
Fertilising Products Regulation (EU) 2019/1009
United States: FIFRA pesticide registration, TSCA, fertilisers, EPA OCSPP 810 efficacy guidelines
Other markets, including Canada, Australia and Brazil, on request
Discuss a mandate
Discuss a mandate
Tell us the product, the framework and the markets you target. We work from Hong Kong and France with clients in Europe, Asia and beyond.
We advise and prepare. We are not a marketing authorisation holder, manufacturer of record, or notified body. Statutory responsibility stays with the client.
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