WHY REGEXCEL?

"The consultancy has a clear understanding of how to review and best place a product ranging from new active substances (small molecule or biologic), ‘drug-device’ combinations, generics and biosimilars.

We use our extensive Regulatory Agency background to the benefit of our clients by providing realistic technical/regulatory appraisals. We are frank in our assessment of strategies and provide 'straight-forward' feedback. We believe that providing a clear appraisal will help our clients understand the merits and obstacles of their strategy early on and allow them to plan and evaluate their projects".

Dr Brij Patel

(Founder, RegExcel Consulting)

1. KNOWLEDGE

All RegExcel consultants are experienced ex-regulatory agency reviewers (quality, pre-clinical and clinical).

All RegExcel consultants were formerly responsible for review and determination of regulatory recommendations and under delegated powers tasked to make final decisions to approve or refuse regulatory applications. Our experience includes major regulatory submissions ranging from the largest innovator companies to SMEs with their first product.

Therefore, RegExcel consultants are best placed to understand what is likely to meet (or not meet) a positive approval. Our consultants have extensive knowledge of regulatory requirements and processes.

2. AWARENESS

Our consultants have first hand experience of National and European regulatory committees and have given formal scientific advice to hundreds of companies over years. We have an extensive network of former regulatory agency colleagues that can be approached for sounding out new strategies or discussing difficult problems.

Our regulatory experience and network means that the consultancy is aware of various interpretations of National and European policies, differences in views between various EU member states, and the workings of National and European committees and how external stakeholders can influence decisions.