Regulatory Compliance for Your Biocide Products Made Simple
Tailored guidance by a dedicated team of experts to ensure the compliance of your biocide products.
Benefit from Expert Guidance at Every Stage of The Compliance of Your Biocide Products
A team of regulatory experts, toxicologists, and ecotoxicologists to ensure the compliance of your active substances and biocide products.
Regulatory Strategy Consulting
From supplier compliance to data gaps, examine each strategic facet with precision.
• Strategic diagnosis for a biocide product Marketing Authorization (MA)
• Marketing: regulatory cost, budget, timelines, and deadlines
• Compliance of approved suppliers
• Completion of data gaps in efficacy, physico-chemistry, toxicology, and ecotoxicology
• Review of active substances in your product portfolio (analysis of approval dates for SA/TP pairs, obligations of the market operator…)
• Strategic diagnosis for a biocide product Marketing Authorization (MA)
• Marketing: regulatory cost, budget, timelines, and deadlines
• Compliance of approved suppliers
• Completion of data gaps in efficacy, physico-chemistry, toxicology, and ecotoxicology
• Review of active substances in your product portfolio (analysis of approval dates for SA/TP pairs, obligations of the market operator…)
Support for Biocide Product Authorization
Explore the subtleties of the regulatory process for biocide products in Europe with EcoMundo.
• Implementation of transitional measures on the European market • Application for approval of an active substance
• Application for biocide product/family product Marketing Authorization (MA) through National, Union, SAME, or simplified MA procedure
• Technical equivalence: Inclusion in the list of approved suppliers
• Evaluation of exposure and risks (human health, environment)
• Development of a Summary of Product Characteristics (SPC)
• R4BP3 Submission
• Compilation of your data under IUCLID 6
• Sequential or simultaneous mutual recognition
• Implementation of transitional measures on the European market • Application for approval of an active substance
• Application for biocide product/family product Marketing Authorization (MA) through National, Union, SAME, or simplified MA procedure
• Technical equivalence: Inclusion in the list of approved suppliers
• Evaluation of exposure and risks (human health, environment)
• Development of a Summary of Product Characteristics (SPC)
• R4BP3 Submission
• Compilation of your data under IUCLID 6
• Sequential or simultaneous mutual recognition
Joining a Consortium
Experts in consortium management, MA, and client representation, ensuring confidentiality and transparency.
• Consortium and confidentiality management among members
• Implementation of MA strategies for product families
• Expertise in toxicology, ecotoxicology, regulation, efficacy, and physico-chemistry.
• Monitoring contacts with competent authorities
• Third-Party - Representation of client interests
• Consortium and confidentiality management among members
• Implementation of MA strategies for product families
• Expertise in toxicology, ecotoxicology, regulation, efficacy, and physico-chemistry.
• Monitoring contacts with competent authorities
• Third-Party - Representation of client interests
Additional Services Available
Ensure the compliance of your biocide products with our dedicated team of experts, offering tailored support and personalized ancillary services.
• Evaluation of Endocrine Disruptor (ED) properties of active substances and co-formulants
• Purchase of the LoA for the active substance and registration in Article 95
• Testing monitoring (implementation of tests and monitoring trials until the validation of the study report)
• Validation of labeling, advertising, and claims
• Follow-up of files with authorities (ANSES, ECHA, etc.)
• HELPDESK - Dedicated regulatory, toxicology, and ecotoxicology experts
Have a specific request?
• Evaluation of Endocrine Disruptor (ED) properties of active substances and co-formulants
• Purchase of the LoA for the active substance and registration in Article 95
• Testing monitoring (implementation of tests and monitoring trials until the validation of the study report)
• Validation of labeling, advertising, and claims
• Follow-up of files with authorities (ANSES, ECHA, etc.)
• HELPDESK - Dedicated regulatory, toxicology, and ecotoxicology experts
Have a specific request?
Personalized Approach for Each Client
Our team of biocide compliance specialists works closely with you to understand your products, challenges, and goals. We then develop a customized strategy to guide you through each stage of the compliance process.
The EcoMundo Difference: A Unique Methodology for Managing Each Regulatory Stage of Your Biocide Products
A Team of Regulatory Experts, Toxicologists, and Ecotoxicologists
Meet our team of biocide compliance experts! Their academic qualifications and certifications, combined with their market expertise, make them essential trusted partners in your compliance journey.
Stay Informed about Biocides News with EcoMundo
Biocide Alliance: Regulatory Expertise in Biocides
Stay at the forefront of news in the biocides field with EcoMundo, your expert partner in regulatory compliance.
- Regulatory newsletter
- Monitoring of regulatory obligations according to your active substances
- Training tailored to members
- Diagnosis of your obligations
- Development of regulatory strategies
Ensure the regulatory compliance of your biocide products with EcoMundo's experts!
Contact an Expert
