Niche can contribute to customised regulatory strategy planning to mitigate the risks associated with clinical development. Our experience of communicating with regulatory authorities means we effectively manage submission decisions and documentation leading to a smooth and rapid approval process.
We tailor our involvement to your needs: providing assistance in preparing communications right through to managing the complete submission process, sitting in on meetings with regulators when required.
Our fully flexible service means we are always available to provide support for any aspect of a submission or the entire package.
