RegExcel Consulting
Helping you get regulatory approval
info@regexcelconsulting.com
Please contact us for a free no obligation discussion about your service needs.
"A
Regulatory
Consultancy
with
Agency
Roots".
"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)
Why Work
With
RegExcel?
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.
3. DELIVERY
We will provide clear and focussed feedback to our clients
within agreed timelines.
The aim of our feedback will be to highlight any regulatory
risks, suggest mitigation strategies, and to add value to our
client's product.
Our goal is to support timely development of the product and improve positioning of the product for regulatory approval.