About
Dr. Bonarius Consult GmbH provides comprehensive Regulatory Affairs expertise and organisational and project management services for the pharmaceutical, chemical and related industries, complemented by tailored training and development programmes for R&D and Regulatory Affairs teams. With over 20 years of international experience, the company supports regulatory strategy, marketing authorisation processes, due diligence and M&A portfolio integration, as well as digital transformation through AI-driven solutions and targeted workshops at strategic, operational and shop floor level.
Dr. Bonarius Consult GmbH was founded in August 2018, in parallel to my job as Global Head Regulatory Affairs for Siegfried AG, in order to provide training, coaching and mentoring of Regulatory and R&D professionals.
In October 2019, after a career spanning twenty years’ experience as scientist, consultant and lastly as a global department head, I left Siegfried AG to become fully independent.
I do believe in the importance of networking in improving the regulatory landscape. Throughout my career I have worked in various industry associations and committees such as the International Federation of Animal Health (now AnimalHealth Europe), the European Biocidal Products Forum (EBPF, member of CEFIC) and the Active Pharmaceutical Ingredients Committee (APIC, member of CEFIC). In 2014, I founded the Association of Chemists in Industry, section Freiburg ("Verein für Chemiker in der Wirtschaft", VCW, part of the German Chemical Society).
Today, I am an active in several chemical, pharmaceutical and regulatory organisations:
- The Organisation for Professionals in Regulatory Affairs
- German Chemical Society
- Verein für Wirtschaft und Chemie
- Regulatory MasterMinds
My background
- More than twenty years’ experience in as scientist, consultant and global department head, latterly and most importantly in Regulatory Affairs.
- International regulations of pharmaceuticals, veterinary products, crop protection, biocides and chemicals, in particular marketing authorisations, metabolism, dietary residues and product safety.
- Leading teams, projects and improvement initiatives, e.g. integration of mergers and acquisitions, training for inspection readiness, process mapping, SOP review following warning letters, establish regulatory information management processes and systems.
- Coaching and development of senior management, leaders and teams.
- Familiar with different cultures and working styles (US, Europe, China).
- Negotiation with all health authorities and governing bodies.
- Speaker on regulatory training courses for the German Chemical Society and Medicademy (now Atrium).
- PhD (Dr. rer. nat.) in chemistry from the University of Marburg, Germany.
- Additional certificate as a quality expert (TÜV Süd).
How I work
I treat any discussion with potential, current or previous clients as confidential. Confidentiality is maintained throughout a project and indefinitely unless disclosure is required for legal reasons.
Dr. Bonarius Consult works with a range of companies and reserves the right to simultaneously work for competing clients in areas that do not directly conflict. If there is any doubt that a conflict of interest may arise, I will discuss this with the concerned parties while maintaining client confidentiality at all times.
Listen and learn: I am happy to discuss your project in confidence and with no obligation. Following discussion to fully understand your requirements and processes, I will provide a quote for my services at no charge.
Sometimes a short preliminary analysis or work may be necessary to clarify next steps or strategies. In such cases a fixed fee will be agreed beforehand. Following that, I shall provide you with a proposal for the full project, and you are then free to accept.
Remuneration
- By time: per day or hour on an agreed professional rate. The total can be capped by agreement, avoiding surprises.
- By project: an agreed fixed fee, depending on the nature of the work and the size of the project.
- By retainer: allows for continual services over a period of time. A retainer fee is agreed and invoiced regularly and you can draw on Dr. Bonarius Consult as needed, up to an agreed limit.
