RegExcel Consulting
Helping you get regulatory approval
info@regexcelconsulting.com
Please contact us for a free no obligation discussion about your service needs.
Regulatory
Services
RegExcel provides consultancy services for:
Delivery of Services Through Experienced Advisors
Our staff have previously worked as regulatory assessors/inspectors at the MHRA and EMA. They have reviewed all types of applications from full new applications to post-approval variations, for some of the biggest pharmaceutical companies in the market.
Drawing from this background we aim to provide our clients with a
clear understanding of which regulatory strategy can be achieved,
which requirements need to be negotiated and which areas will face
resistance. Our clear and honest appraisals provide our clients
with clear choices to review and balance their strategy against
their individual circumstances and project goals.
Contrary to popular belief, there is often room for negotiating
with the regulators. Often, decisions can be subjective and
policies and interpretations are open to debate. However with
experienced advisors you will be best place to understand the
dynamics of how regulatory decisions are made, when to engage with
the regulatory agencies and how to progress your submissions to
seek a positive outcome.
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