Understanding the Clarbonyx Commitments: Why Clarbonyx Services are "Obligations of Means"

In the complex landscape of life sciences, bioscience engineering, and regulatory affairs, the path to a successful outcome is often influenced by evolving scientific data, shifting regulatory signals from the EMA or FDA, and the inherent variables of pharmaceutical research. Topics like nitrosamine impurities in medicines are not static, as both the science and regulatory frameworks continue to evolve.

Because of this complexity, Clarbonyx bv operates under the legal principle under Belgium law of an “obligation of means” (middelenverbintenis).

What is an “Obligation of Means”?

In legal terms, an obligation of means implies that the service provider commits to acting with due diligence, prudence, and according to the "state of the art" in their field.

Unlike an "obligation of result" (resultaatsverbintenis), where a specific outcome is guaranteed (such as a manufacturer producing a medicine to exact specifications), an obligation of means focuses on the quality of the effort. As your consultant, we pledge to deploy all our expertise, specialized tools, and professional care to help you achieve your goals, but we do not guarantee a specific end-state, such as a guaranteed approval from a regulatory body or a specific laboratory outcome.

Why This Matters in Life Sciences

There are three primary reasons why our consultancy outputs are defined this way:

  1. Regulatory Uncertainty: Regulatory agencies like the EMA or US FDA are independent bodies. While we provide the best possible strategy based on current guidelines (such as those regarding nitrosamine impurities), the final decision rests solely with the authorities. Additionally, we have no control over how our Clients use or implement the recommendations in a regulatory context.

  2. Scientific Evolution: In life sciences and organic chemistry, new data can emerge overnight. What is considered "best practice" today may be updated tomorrow. In the field of nitrosamines, industry consortia like HESI GTTC NRP or (advanced software) initiatives (like the work of Lhasa Ltd) continue to work on evolving science. Our commitment is to stay up to date with these evolutions to the best of our possibilities, but not to predict what the science of tomorrow will bring.

  3. Third-Party Dependencies: Our advice often relies on data provided by Clients, external CMOs or laboratories. We cannot guarantee a result that depends on the accuracy of third-party technical inputs.

How We Measure Success

While we do not guarantee a specific result, our commitment to the "means" is rigorous. A middelenverbintenis does not mean a lack of accountability. Instead, it defines our accountability as:

  • Providing advice based on the most current regulatory frameworks while using evidence-based approaches and combining science with compliance.

  • Utilizing advanced expertise and current industry standards to conduct assessments with scientific rigor.

  • Acting as a prudent and reasonable professional (in accordance with the standard of care expected of a scientist and life science consultant) in every analysis and report we deliver.

  • Providing our Clients with detailed motivations on the recommendations and positioning of data proposed.

  • Interacting with the Clients to understand their professional opinion on the advice we provide and keeping an open mind in discussions.

At Clarbonyx we understand that at the end of the day the strategy that is executed is based on the decisions of the Client, and we are respectful of the independence of the Client in deciding if and how to use our recommendations.

The Impact on Professional Liability

By defining our outputs as obligations of means, we ensure a fair and balanced professional relationship. Liability only arises if it can be proven that we failed to exercise the standard of care expected of a specialist in the field. This allows us to provide deep, high-level technical insights without being held responsible for external factors beyond any consultant’s control. Our liability is detailed in our Terms of Service to which this explanatory note on the concept of an obligation of means is added.

Conclusion

At Clarbonyx bv, our "means" are our greatest asset: a unique blend of science and regulatory insight. By focusing on the highest standards of professional conduct, we provide our clients with the most robust technical and regulatory support available in the industry today.