Planning your regulatory strategy should be done at the earliest possible stage of product development. The regulatory plan identifies important regulatory requirements to be addressed and describes the product development plan noting the needs that vary between markets. Each market may have different regulatory requirements, language considerations, unique data privacy procedures, varied medical practices and unique commercialization requirements to consider and integrate into the broader business plan aimed at attainment of worldwide approvals.
With the Innovenn team supporting your regulatory strategy, we will help you align the product claim or intended use with the medical device classification and the competitive landscape. The starting point for success envisions the needs of patients worldwide. We will help you implement the strategy, summarize the evidence, and submit the needed dossiers to regulatory authorities to support worldwide regulatory approvals, product adoption and market success in Health Innovation.
Our regulatory planning and submissions consulting services include the following:
