Comprehensive and robust data packages are required to support risk assessments for biocidal products. Our analytical experts have considerable experience with both the generation of validation data and the evaluation of data used to support registration. As an independent consultancy, we can assist in placing and monitoring studies to ensure that all data requirements are met, or by providing support when resolving issues with regulatory authorities.Analytical chemistry issues are often raised during the evaluation process. Whether this relates to data in support of the technical specification, or analytical methodologies for pre- and post- registration, regulators are critically evaluating data to ensure that all methods are robust and have been suitably validated for their intended purpose. Where data gaps are identified, further validation may be required, which could lead to the repetition of expensive studies. Typical areas of concern include the complex issues around confirming the identity of impurities in the technical material and the validation data required for confirmation techniques.
The standard approach to study monitoring would typically involve a single expert taking the lead. At JSC, one of our key strengths is our integrated approach across all disciplines, allowing us to monitor studies effectively and comprehensively, ensuring that all areas, including method validation, are properly considered. We see collaboration between experts as an essential part of ensuring a quality product.