The chances of achieving a marketing authorisation for a new product depend not just on the quality, safety and efficacy of the medicine, but on how clearly these attributes are characterised and documented by the development programme. We can help to ensure that the clinical development plan is optimal to provide the data expected by the CHMP for a potential positive opinion, while taking account of commercial and practical realities. We have a clear and up to date understanding of the data that the CHMP would require prior to approval, and what might be acceptable to be provided as a post approval commitment.

Formal CHMP scientific advice sometimes describes an ideal view of the clinical development programme and clinical trial design that the CHMP would most like to see.  Some aspects of the advice may be more onerous than alternative approaches that might in principle be sufficient to support a MA application. On the other hand there are likely to be aspects that are essentially mandatory. There is no obligation to follow the CHMP advice, but it would be unwise to do so without a clear understanding of the potential consequences. We can help to clarify where the advice should be complied with and where a different approach might be reasonable, taking into account practical considerations such as time and/or resource limitations.

Preparing the dossier for a Marketing Authorisation Application (MAA) is a major undertaking. We can review proposals for the structure and content of the clinical parts of the dossier perform gap analyses, and give advice on how best to present the data so that assessors are able to find the information that they need quickly and easily, thereby minimising any difficulties later during the MAA procedure. 

We can help companies with the written responses to the CHMP's list of questions, especially any major objections, so that the responses provide the best possible data, discussions and justifications to reassure the assessors and the CHMP.  

If an application reaches the stage of requiring an oral explanation or a re-examination procedure , it is critically important to fully understand the nature of the CHMP's concerns and how best to address them. We have a deep understanding of how the current CHMP members think and we can provide the best possible advice on how best their remaining concerns might be addressed. 

Our expertise in evaluating clinical trial data is of value not just for regulatory purposes. In early drug development, key decisions regarding future investment in the molecule are often taken based on very limited data, around which there are considerable uncertainties. The parties making the investment decisions may be dependent on others for the relevant scientific evaluations.  We can provide an expert view on the conclusions that can reasonably be drawn from the available early phase clinical data, considering the robustness and reliability of the results, and the likelihood that encouraging looking results might be due to factors other than a true and clinically relevant treatment effect.