Dossier Preparation
We offer comprehensive services for the preparation of registration dossiers for chemicals under REACH, for plant protection products and their active substances, for biocidal products and their active substances, for feed additives, as well as the preparation of regulatory documentation for household detergents and of technical documentation supporting market access and compliance of fertilising products and biostimulants.
Our focus is on the structured compilation, authoring, formatting and quality control of complete dossier and documentation packages for submission at EU and Member State level. We combine scientific accuracy, regulatory clarity and strong internal quality control to support efficient authority review.
Plant Protection
Based on Regulation (EC) No. 1107/2009 and Commission Regulations (EU) No. 283/2013 and No. 284/2013, we prepare high-quality regulatory dossiers for active substances and plant protection products in line with current EU requirements. We transform complex scientific and regulatory information into clear, consistent and submission-ready documentation that meets formal, technical and content-related expectations.
Our services include dossier structuring and planning, compilation of complete dossier packages, scientific and regulatory writing, integration of technical contributions, data presentation and consistency checks, gap-oriented dossier refinement, preparation of active substance dossiers, preparation of product authorisation dossiers, and final document review before submission.
Biocides
Dossier preparation under Regulation (EU) No. 528/2012 for active substances and biocidal products in line with current EU requirements. Our dossier preparation services include dossier structuring and planning, compilation of IUCLID-based dossiers and related technical documentation, scientific and regulatory writing, integration of contributions from toxicology, ecotoxicology, efficacy and exposure-related disciplines, consistency and quality checks, preparation of active substance dossiers, preparation of product authorisation dossiers, and finalisation of submission-ready document sets.
Feed Additives
We prepare high-quality regulatory dossiers for feed additives in line with current EU requirements, based on Regulation (EC) No. 1831/2003, for authorisation procedures, renewals, modifications and related regulatory pathways.
We offer dossier structuring and planning, compilation of complete technical dossier packages, scientific and regulatory writing, integration of safety, efficacy, analytical and manufacturing-related information, consistency and quality checks, preparation of authorisation dossiers, data presentation and dossier refinement, and final technical review before submission.
Household Detergents
We support the preparation of regulatory documentation for household detergents and related surfactant-based products based on Regulation (EC) No. 648/2004, focussing on the structured compilation, authoring, formatting and quality control of product-related compliance documentation to support market access, product stewardship and ongoing regulatory compliance.
The service includes planning of regulatory documentation, compilation of technical product files, scientific and regulatory writing, integration of formulation, toxicological, biodegradability and labelling-related information, consistency and quality checks, support for ingredient and composition documentation, preparation of documentation for compliance reviews, and final document review.
Fertilizing Products, Biostimulants
High-quality regulatory documentation for fertilizer products in line with EU, German and other memberstates’s specific requirements, based on Regulation (EU) 2019/1009 for CE-marked EU fertilising products and national frameworks for non-CE products. We focus on the structured compilation, authoring, formatting and quality control of technical documentation supporting market access and compliance.
REACH
Based on Regulation (EC) No. 1907/2006, we prepare regulatory dossiers and supporting documentation for substances under REACH in line with current EU requirements. Our work covers the development, consolidation and refinement of technical documentation needed for registration, updates, dossier maintenance and other substance-related regulatory obligations.
We support the preparation of robust dossier packages by translating complex scientific, technical and administrative information into clear, coherent and submission-ready documentation.
