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Dear Customers, Dear Business Partners,

Our company is here to serve you. Always fair, independent and of high quality, we meet you where you are. We want to build long lasting relationships where we work together trusting each other. Our services are constantly adapted to your needs. We look forward to hearing from you.
Kind regards,
Dr Gunnar Kleist

Dr. Gunnar Kleist Director Regulatory Affairs
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March 4, 2024
Dream team brings regulatory expertise in-house
With a real "dream team", Dr. Brill Institutes will be able to offer customers from industry its own Regulatory Service in the future. Heike Schimmelpfennig and Dr. Gunnar Kleist, each with two decades of regulatory experience in different areas of industry and public authorities, offer a 360-degree view of chemical testing and approval of biocides (active substances and products). "With our wealth of experience from different perspectives, we are unique on the market," explains Dr. Gunnar Kleist confidently. "We offer our customers holistic project management, which can take five years from the first kick-off meeting to approval, depending on the process." The two are more than trustworthy sparring partners in a process that demands complete transparency and honesty from the customer. Thanks to its many years of experience, the Regulatory Services team is also able to master critical situations at short notice when companies get lost in the complex European chemicals legislation or miss important deadlines, which can sometimes threaten their existence. However, both prefer to work with the customer from the start of the process in order to avoid precisely such crisis situations. "In our role, we also see ourselves as a mediator between the needs of industry and the expectations of the authorities," says Heike Schimmelpfennig. "We know what the authorities want, but we also know the needs of industrial customers." Heike Schimmelpfennig has ten years of experience in the environmental risk assessment of chemicals in both a consultancy firm and an EU regulatory authority. Dr. Gunnar Kleist contributes his more than 20 years of corporate experience in industrial research, test method development and Regulatory Affairs. Their joint core competence is to incorporate all relevant information from their profound knowledge of internal company processes into an approval application in such a way that a smooth and successful completion of the entire procedure is guaranteed. The Regulatory Services are an independent island in the Dr. Brill family because their services can be booked independently of laboratory operations. The efficacy tests required for product approval can, but of course do not have to, be commissioned from Dr. Brill + Partner. However, the short line to the technical expertise of the associated test laboratories and the possibility of commissioning time-critical data packages at short notice within the network can be a decisive advantage for the customer in the approval process. Dr. Florian Brill, Owner and Managing Director of Dr. Brill Institutes, sums it up: "With the integration of Dr. Brill Regulatory Services GmbH into the Dr. Brill Institutes Group, we have gained a decisive new building block that will help us strategically. We are bringing regulatory expertise in-house. A large part of our work in the various laboratories results in an approval dossier according to BPR, for example, and now we can deliver this. Dr. Brill Regulatory Services was the missing component - and with Gunnar and Heike we have gained two superstars of the scene. I want them in my team and so do our customers. I'm really looking forward to everything else." In the coming weeks and months, the new Dr. Brill Regulatory Services team will be presenting itself to clients at conferences and presentations. Dr. Gunnar Kleist: "It is important that clients build up a basis of trust with us and also realize what makes us special. That we don't do anything by the book, but always create the best case for the customer. As a rather small team, we deliver what we promise with our personal expertise!" If you would like more information about our new service, please contact Heike Schimmelpfennig ( or Dr. Gunnar Kleist (  


The Biocidal Products Regulation (EU) No. 528/2012 (“BPR”), which is now in force throughout Europe, was introduced in July 2012 and is considered to be the most demanding biocide legislation in the world. It is more comprehensive than the previous Directive 98/8/EC and covers more active substances and products.

In-situ active substances and their precursors that could be used to generate an active substance are now covered, as are articles treated with biocidal products. In the case of detergents and cosmetics, biocidal product claims (e.g. antibacterial, antiviral) can also have serious consequences for the immediate marketability of your product. In addition, there are dual-use surface disinfectants in the healthcare sector that must comply with both biocidal and medical device regulations. All this places high regulatory demands on the developers and distributors of such products.

We are aware of these major challenges. We offer you competent advice and active implementation assistance: We'll work with you to find practical registration solutions. We'll help you navigate the authorisation process with the authorities and guide you safely through the EU's national transitional measures. Benefit from our experience and speed.

Who we are

We are experts in our field. When dealing with regulatory issues, we always look at what's commercially viable and what's going to work. Throughout the process, we do more than just compile documents for you - we are part of the thinking. Our contribution can range from modules to complete packages. We know when a small investment can make a big difference to the attractiveness of your products. We are convinced that we can add real value to your business: Reduced complexity and cost efficiency combined with safety and growth opportunities. You can rely on us to provide a high-quality service, backed up by our extensive regulatory experience and a large network of reliable partners.

Our key regulatory services for biocidal product approvals:

  • Development of BPR registration strategies, including the creation of tailor-made product family concepts.
  • Helping to negotiate Letters of Access (LoA) to obtain data  
  • Project management and study monitoring (initiating and follow-up)
  • Classification and labelling of substances and products in accordance with CLP/GHS
  • Exposure and risk assessment of active substances and biocidal products for humans and the environment, including substances of concern (SoC) and the assessment of endocrine disrupting (ED) properties.
  • BPR dossier preparation, including IUCLID file, Product Assessment Report (PAR) and Summary of Product Characteristics (SPC), as well as dossier submission via R4BP and subsequent handling of queries from the authorities.
  • Regulatory support: Providing individual dossier modules in IUCLID and PAR (e.g. efficacy, physicochemical properties).
  • Notification/registration/authorisation of products in all EU Member States under national transitional law (safeguarding as "existing product" prior to BPR post-authorisation to ensure continued marketability through the evaluation process).
  • Advising on borderline issues and the status of treated articles and their labelling
  • Training courses and workshops (also tailored in-house to meet your specific needs), including preparation for the comprehensive and restricted examination under the German Chemicals Prohibition Ordinance (with/without biocides and plant protection products).