About Us
About Us
Regulatory Solutions was set up by Karen Baker FRSC
at the beginning of 2011. We are an independent regulatory consultancy and aim to provide cost effective services to the agrochemical industry.The majority of work is done in house, but we also work with a trusted network of expert consultants to enable us to provide solutions for all of your regulatory requirements.
In addition to conventional active substances, we have specific experience working in biopesticides, notably plant extracts. We have worked with new active substances to achieve approval in Europe and also product authorisations at national level.
Meet Our MD
Karen is a regulatory expert with many years’ experience gained both in industry and consultancy in agrochemicals. She is experienced in the provision of regulatory advice and has developed cost effective regulatory strategies for a range of clients. She has completed data gap analyses, placed and monitored a wide range of regulatory studies, written many successful waiver arguments and written complete active substance and product dossiers. She is also fully trained in classification and labelling including MSDS production.
After graduating from the University of York with a First Class Honours degree in Chemistry, Karen initially worked as a research and development chemist in industry. Having decided that this was not her long term career ambition, she joined the regulatory affairs team, where she stayed for 10 years, finally attaining the role of Registration Manager. In this role she worked on registrations globally, including Europe. As part of the EU review programme, she was responsible for writing a complete Active Substance dossier and successfully took that through to Annex I listing under 91/414.
From there Karen went on to work for a major international consultancy in the role of Regulatory Affairs Manager and then subsequently for another consultancy as Director of Regulatory Affairs. In this role she set up a new office and facilitated its growth into the main office for the company. She worked closely with clients in the role of project manager, understanding their needs and working with the project team to deliver timely regulatory submissions ranging from simple label updates through to new active substance submissions.
Karen is a general regulatory expert and prides herself on being able to work effectively on all sections of the dossier. From data gap analysis, to dossier writing and risk assessment, she has a good understanding of the regulatory requirements across the entire dossier. This skill means that she is able to provide comprehensive and effective advice, understanding the impacts on other sections and providing the complete solution.
Our Services
Consulting
