Our safety assessment includes adequacy of the safety data on medical products, including organization’s own safety information on the product, manufacturing, and quality aspects. We cover pharma, biotech, MedTech product, it may be an evolving product or existing/marketed product.
Our safety assessment includes details of safety from all phases of completed clinical trials including the organization’s own safety information generated on the product. In the case of safety assessment for existing/marketed products, apart from company’s data, we search comprehensively for suitable published literature for potential product class safety concerns and explore potential directions and assist in compiling scientific writeup that may be presented to reviewing authorities.
Our overall approach is based on the health agencies’ approach – using a multidisciplinary approach. Our review, guidance, compilation can support an application for new clinical trial on the product, submission of marketing application or planning of next/additional clinical trial or additional non-clinical studies.
