Regulatory Affairs​

Check of completeness and data gap analysis, strategic advice and recommendations​

Study management and monitoring of relevant GLP studies for physical and chemical properties, analytical methods, residues, environmental fate & behaviour as well as ecotoxicology​

Dossier preparation and compilation for EU approval of as well as renewal of approval of active substances​

Preparation of the zonal core dossiers and national addenda for product registration in the EU (dRR, MRL applications, LEX) for dossier sections on identity, physical and chemical properties, analytical methods, residues, environmental fate and ecotoxicology​

Summary reports of method validation to fulfil the European data requirements for risk assessment methods (SANCO/3029/99 rev. 4/drafted rev. 5)​

Consumer risk assessment, ecotoxicological risk assessments (incl. higher tier approaches), modelling/exposure assessment (incl. higher tier approaches)​

Tier 1 and higher tier pollinator risk assessment and MRL setting in honey​

Country specific bee risk assessment for Belgium and Austria according to EFSA Guidance Document (2013)​

Continuous support of national registrations mainly in EU member states but also in other countries around the globe ​

Bridging statements for demonstration of comparability of product formulations​

Pre- and post-submission support​

Literature searches and reviews (Regulatory Science)​

Recently we hired a number of experienced experts and from now on, we are able to provide a full registration support of active substances and PPP in the EU. We have scientific experts for identity, physical and chemical properties, analytical methods, metabolism and residues, environmental fate and ecotoxicology. For the toxicology and human exposure section, we are working together with an external partner.

Our experts have detailed knowledge of data requirements for the registration and re-registration of active substances and PPPs as specified in current EU legislation, country-specific regulations and current guidance documents. The strong technical knowledge of the registration support team ensures fast and effective work, coupled with reliable regulatory compliance.

Why we have the expertise

This expertise is augmented by a deep reservoir of in-house specialist knowledge provided by senior staff members, which can be mobilised to handle complex authority requests or other non-standard situations that may arise during the registration.