Auditing
Data
Many clients may already have a product and dataset available,
perhaps a product that has already enjoyed success in territories
outside the EU. One of the most valuable services we provide
is the audit of these data against the very precise requirements
of EU legislation. Cyton’s audit reviews each piece
of existing data and from this identifies a list of critical
issues that need to be addressed or resolved, together
with the budget and timetable to achieve successful marketing
authorisation in the EU. This audit can be tailored where
necessary to include regulatory strategy proposals and
detailed product development plans and costs.
Writing Submissions
Much of Cyton’s expertise lies in writing marketing authorisation
applications. Cyton’s
ability in writing coherent submissions and preparing critical
summaries on Quality, Safety and Efficacy, using our own
in-house Experts, is central to the success of a Cyton marketing
authorisation application.
A dossier prepared by Cyton will satisfy the requirements of EU
legislation and the most demanding EU authority.
Managing Procedures
As the EU grows, the physical management of the submission process has become
more involved. We
obtain all translations, prepare the submission, manage
the payment of fees and handle the regulatory procedure
on your behalf. Cyton’s team prepares the responses
and then actively monitors the progress of your submission,
contacting
EU
authorities
on your behalf to ensure that assessment timelines are
rigidly adhered to. Our effective organisation, coupled
with excellent communication, puts you in control
of your submission at all times.
|
