The pathway required to bring a new therapeutic product to realization can be complex. With subtle changes early the development program having a negative impact.
A thorough and critical analysis of the regulatory strategy and intended pathway can identify any potential gaps and address potential challenges before they occur.
Through our experiences in the regulatory development process, Plunkett Consulting Group can undertake an effective and detailed analysis of our clients strategy, data collected so far and intended next steps, with the outcome being a summary of any gaps identified and our proposed steps to mitigate these effectively.
We can also provide you with a development plan intended to support proof of concept right through to marketing authorization.
Get in contact with us to see how we can assist.