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Technical Support

Technical Support for analytical and efficacy-related issues – clear, practical, and regulatory sound.

We offer technical support for biocidal and plant protection projects, focusing on expert assessment, methodical classification, and clear, project-specific coordination. The scope of services is deliberately limited to technical support for product-related issues and does not include operational assistance with approval procedures or dossier preparation.
The focus is on analytical and efficacy topics relevant to product development or approval preparation. We support our clients in the technical interpretation of regulatory requirements and their transfer to suitable testing strategies.

Efficacy Tests

Technical Consulting at a Glance

Regulatory Data Packages

BioGenius supports you in compiling complete regulatory data packages for approval procedures, including safety and efficacy data, physicochemical parameters, and targeted testing programs. The composition of the data packages is project-specific, aligning with the respective approval requirements, relevant regulations, and market regimes.

Methods & Practical Testing

We advise on adapting existing test methods and developing new testing procedures when standardized protocols are insufficient or unavailable. The goal is to align methods practically with your product characteristics and application scenarios, thereby maximizing the informative value of the results for approval and application questions.

Statements & Documentation

BioGenius prepares expert statements, methodical explanations, and results documentation in a structured and comprehensible manner. This includes the factual classification of study results, the explanation of methodical decisions, and the creation of accompanying reports for internal or external requirements within the scope of approval and quality assurance.

Guidelines & References

Our consulting is based on relevant international standards, guidelines, and reference documents, e.g., EU Biocidal Products Regulation (BPR), REACH, Test Methods Regulation (EC 440/2008), CIPAC, OECD guidelines, and other international standards. We help you classify these references within your project and study design and implement regulatory requirements practically.

Industries

Who is this relevant for?

Regulatory Affairs & Approval

When classification, requirements, and documents need to be coordinated in a structured manner within the project context.

Manufacturers of Biocidal & Plant Protection Products

When support in the approval process and project-related documentation for the product are required.

Product Development
& R&D

When test strategy, methodology, and documentation need to be consistently integrated.

Quality & Project Management

When reliable data and a comprehensible structure are important for internal and external processes.

Alexander Brux
Your EXPERT

Alexander Brux

Managing Director

FAQ

Frequently Asked Questions

Answers regarding approval support, data packages, and references in a regulatory context. For specific inquiries, please feel free to send us a project request.

BioGenius offers comprehensive expert and technical advice for planning suitable study strategies. This includes assessing product status, identifying potential challenges, and defining meaningful test designs for analytics and efficacy. The goal is to develop a reliable and regulatory-appropriate data strategy early on.

Technical support helps integrate regulatory requirements into study planning at an early stage. BioGenius assists in preparing suitable data packages, interpreting guidelines, and preparing arguments for authorities (e.g., in the form of meaningful statements). This can reduce risks in the approval process and make development times more efficient.

Yes, the development and adaptation of test methods are a central component of technical support. If existing standard methods are insufficient, BioGenius develops specific analytical or efficacy methods upon request or adapts existing procedures to the respective product and its application. This is particularly relevant for innovative formulations or new application areas.

Yes, within the scope of technical consulting, analytics and efficacy testing are considered holistically. BioGenius develops integrated testing strategies that link analytical data (e.g., active ingredient content, stability, or residue analysis) with efficacy evidence. This creates consistent data packages for development, claim support, and regulatory requirements.

Collaboration usually begins with an analysis of the product and the objectives. Based on this, possible testing strategies, methods, and study designs are developed. BioGenius accompanies the entire process – from conception to execution and the preparation of results for regulatory purposes. If required, coordination with authorities or the preparation of technical statements can also be supported.

SERVICE CATALOG

Get to know BioGenius

If you are planning a project in analytics, efficacy, or approval, we would be happy to discuss the objective, setup, and timeline.

SERVICE CATALOG
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