Our Services

Plant Protection Products 

  • Project development and management

  • Data gap analyses

  • Development of pragmatic regulatory approaches and strategies

  • Pre-submission activities and discussions with regulatory authorities

  • Dossier preparation including IUCLID and CLH reports. 

  • Documentation services like dossier submission or CADDY preparation

  • Dossier defense and follow up with authorities

  • Preparing of expert statements and tailored risk assessments

  • Preparation of CLH reports

  • Design and monitoring studies.

  • Adaptation of study methodologies for biopesticides and other reduced-risk products.

  • Coordination of programs for efficacy testing in all EPPO zones

  • Development of new products and formulations

Biocides

  • Project Development and Management

  • Data Gap Analyses

  • Development of pragmatic regulatory approaches and strategies

  • Pre-Submission Activities and Discussions with Regulatory Authorities

  • Dossier preparation including IUCLID, SPCs and (product) assessment reports

  • Documentation services like dossier submissions

  • Dossier defense and follow up with authorities

  • Preparing of expert statements and tailored risk assessments

  • Preparation of CLH reports

  • Design and Monitoring Studies.

  • Adaptation of study methodologies for micro-organism based (low-risk) substances and biocidal products

  • Coordination of programs for efficacy testing

  • Development of new Products and formulations

Biostimulants

The new EU Regulation for fertilizing products covering Plant Biostimulants has been adopted recently by the EU parliament and implementation at national level is still proceeding. We keep you updated about changes at EU and national level.

  • Scientific and Strategic advice prior to and during product development

  • Assistance in contact with authorities

  • Study design and monitoring

  • Coordination of programs for efficacy testing

  • Project management

  • Literature Research and preparation of Expert Statements

  • Submission of the applications to Member States

  • Documentation work including printing

  • Post-application monitoring

Laboratory Services 

Our GLP laboratory in the UK provides guideline and bespoke studies for all classes of biopesticides and conventional Plant Protection Products, with particular expertise in terrestrial, freshwater and marine ecotoxicology. Batch analysis, microbial and chemical contaminant screening, storage stability and phys-chem testing, Quality Control screening, environmental fate and non-target plant studies are also conducted for our global client base. 

The combination of regulatory and laboratory expertise with biopesticides is unrivalled, and is part of what makes APIS unique.

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