Consulting on varroa treatment registration is a core area of expertise for BeeSafe. These are the steps we go together to make sure your application meets the requirements of the EU regulation:
- If you’re completely unfamiliar with the process, you get an introduction of the whole procedure for registration of varroa treatments. This is helpful for you to know what to expect, how long it takes, the costs, etc. If you already know, we start at the next point.
- In this step you get a detailed data gap analysis from the studies you already have. I look through all the studies if they apply to the requirements of the EU. This step shouldn’t be skipped. I do this to make sure that all the data are compliant with the regulations. In some cases, a rearrangement in the presentation of the data may be sufficient. In others, additional studies may be necessary. You get a detailed roadmap with timelines and costs for your particular product.
- When all the data are complete, it’s time to start with the process of dossier writing.
Areas of consulting on varroa treatment registration
BeeSafe offers consulting services for the pre-clinical and clinical part of the dossier (part 4). I also assist in the writing of the SPC and the summaries of the pre-clinical and clinical chapters of part 1 (summary of the dossier). For some background on the work registering varroa treatments check this blog post.
Contact Me for more information
If you have any questions or would like some more detailed information about my services, do not hesitate to contact me. I will answer you as soon as possible