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REGULATORY REQUIREMENTS ARE INCREASING DRAMATICALLY. DO YOU THINK THIS IS A RISK OR A STRATEGIC OPPORTUNITY?
DR. GUNNAR KLEIST
Senior Expert Regulatory
“Biocidal products are torn between the increasing regulatory provisions of BPR (Biocidal Products Regulation), the CLP (classification, labelling and packaging) Regulation, and the REACH (Registration, Evaluation, Authorisation of Chemicals) Regulation. The authorisation requirements in accordance with the new EU BPR pose major challenges regarding financial and personnel resources, especially to small and medium-sized enterprises, when they want to remain marketable in their familiar environment.
Here, we offer professional advice and active implementation support: together with you, we will identify practicable authorisation solutions, safeguard your portfolio by reasonable biocidal product lines, accompany you through the registration process with authorities, and safely see you through national transition measures within the EU.”
DR. JANA ZEILINGER
“Data requirements for biocidal products are complex – a timely start of the project gives you and us enough time to develop the right authorisation strategy. Completeness and quality of the submitted data are a key success drivers here.
We analyse your existing data (data gap analysis), take care of the monitoring of missing studies, create a risk assessment, and consult authorities about the dossier strategy in a pre-submission meeting. Afterwards, we prepare the IUCLID (International Uniform Chemical Information Database) dossier, and submit and keep track of it with R4BP (Register for Biocidal Products) – for your products to be future proof.”
DR. ROLAND KNIELER
“When taking care of regulatory issues, we always keep an eye on the economic feasibility. We know your customers and competitive environment. We do not only compile documents for you. We recognise where little effort can considerably enhance the attractivity of your products. And we see where things can be simplified without inconvenience for your customers. We are convinced that we will add value to your company during a project: in euros, in attractivity, in less complexity, and in growth opportunities.”
YOU HAVE QUESTIONS?
Simply contact us. We are happy to assist you.