Biocides

If you have any doubts regarding the regulation and the concerning guidelines/standards or how to implement them, our experts can help you.

Feasibility studies include:
– Preliminary analysis of your product (is it BPR or borderline product?)
– Project preliminary design
– Experimental plan
– SOCs, EDCs and relevant regulatory milestones
– Business Plan of the regulatory project

BPR one-stop-solution Dossier Management including:
– Consultancy activity
– Risk Assessment
– Experimental Study Monitoring
– Dossier Preparation, Submission and Post-submission
– Communication with Authorities

Design and description of the family approach upon CA-July19-Doc.4.2-Final – Guidance note on BPF concept: assessment of similarity in BPF by:
– Similarity of composition upon each component hazard assessment
– Similarity of Uses
– Similar levels of risk
– Similar level of efficacy

Toxicological and Risk assessment of:
– Substance of Concerns (SOCs)
– Endocrine Disruptive Chemicals (EDCs)
– Persistent Bioaccumulative and Toxicological substances (PBTs)

– Notification, registration and/authorization procedures in European Countries (PMC, SIMMBAD, Real Decreto, HSE notification, etc)
– Communication with Authorities

The step-by-step procedure to achieve Art95 compliance, including:
– Experimental studies for Technical Equivalence / Chemical Similarity
– Regulatory support / liaison for Letter of Access achievement
– Submissions and communication with Authorities

While Chemsafe has no internal laboratory, we can assist you during the testing phase thanks to our vast and versatile network and partnerships for:
– Chemical and stability studies
– Efficacy tests on different Product Types
– Safety endpoints

Chemsafe’s Task Force Management experience and innovative approach as a good balance between costs sharing and companies agile business strategies.