Application and Submission of regulatory applications
We support the preparation, coordination and management of regulatory applications, submissions and related procedural activities across a broad range of regulated product areas. Depending on the applicable framework, this includes support for submissions at EU, national and product-specific level, covering initial applications, authorisations or registrations, renewals, modifications, dossier updates and other follow-up activities.
Application and Submission
Our services are designed to ensure that submission packages are complete, technically consistent and aligned with the relevant procedural requirements and submission formats:
- for plant protection products and active substances, this may include applications submitted to Member State authorities using national systems (e.g. BVL E-Antrag, CADDY) and the submission of dossiers in IUCLID structure;
- for biocides, IUCLID dossiers and SPC-related documentation submitted via R4BP 3;
- for REACH, IUCLID dossiers submitted through REACH-IT;
- for feed additives, application dossiers prepared for submission through EFSA’s E-submission Food Chain platform.
For fertilizing products, we support the preparation of technical documentation and conformity-related submission packages for CE-marked EU fertilising products as well as documentation required for national pathways, including Germany-specific requirements where relevant.
For household detergents, where the regulatory framework is generally less centred on formal pre-market authorisation dossiers, we support the preparation and coordination of technical product documentation, compliance files and authority- or customer-facing documentation used in market access and regulatory follow-up processes.
We assist with the preparation of formal application packages, submission planning, technical submission support and the coordination of timelines, responsibilities and document flows across all involved parties. Where needed, we also support communication in connection with procedural follow-up, completeness checks and submission-related clarification requests. By combining regulatory knowledge with strong project coordination, we help create a clear, efficient and well-organised submission process.
