What is it?
Efficacy refers to the capacity for a product or substance to produce the desired effect or claimed effectiveness. In the case of chemical products this can be an obvious effect, such as a colourant changing the colour of a solution, or it may be a claim which needs to be supported with data, for example, “kills 99.9% of bacteria”. Efficacy forms a key part of the data package for a biocidal product under EU and GB Biocidal Products Regulation.
What you get
Client-focused delivery
Expert consultants
Increase chances of data package acceptance
Eliminate the need for further data generation
Reduce cost and time during EU BPR evaluation
What we offer
Yordas offers a range of services which can be useful throughout the full process for efficacy data generation.
Testing strategy consulting
We can advise on the appropriate testing to perform through our understanding of the EU BPR efficacy guidance.
Ongoing Data Package Support:
Once the testing strategy is developed, we can also contact our approved testing partners and provide ongoing support to improve the overall quality of the generated data package.
Study Summaries
Finally, we can prepare study summaries and summarise the outcomes of the data package which is required for EU BPR submission.
BPR Product Authorisation Application
Beyond our expert support with efficacy, Yordas can also provide the full range of services to prepare a BPR product authorisation application under EU or GB BPR. This includes the authorisation strategy, identification of data gaps through a Data Gap Assessment (DGA), proposing an integrated test strategy (ITS), the full Product Authorisation Report (PAR), communication with Competent Authorities (CAs) which is all overseen by our subject matter experts and project managers.
Our Process
Stage 1: Review
The first stage to establish the efficacy data needed is to identify the claims being made for the specific product. This is typically done through the review of label claims and can be quite general (e.g. “bactericidal, fungicidal and virucidal”) or can be quite specific such as “prevents mosquitos for up to 8 hours”.
Stage 2: Design & Testing
The design of the efficacy data package is then tailored, in accordance with available guidance and test methods, to support the claimed function of the product. Where bespoke test methods are required, we engage in discussions with relevant competent authorities to ensure that these are appropriate and based on sound scientific principles.
Stage 3: Data Generation
Once a testing plan is agreed we will coordinate with our testing partners to generate the data and act as study monitors to address any concerns or issues that arise during the testing process.
Stage 4: Evaluation
Once the results are finalised, we will evaluate them and, if required, can then generate expert study summaries and incorporate them into relevant submission documents for EU and GB BPR.