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Compilation of the pharmaceutical dossiers in CTD / eCTD format
We are able to provide dossiers in the Common
Technical Document (CTD) and / or electronic CTD (eCTD) format, suitable
for pan-European submissions.The compilation of clinical and
non-clinical overviews, Summary of Product Characteristics and Patient
Information Leaflets and labels (in all EU languages).
- Submissions and registrations of pharmaceutical dossiers in European Union
QPS, through our partner PharOS, are able to handle the regulatory
submissions of pharmaceutical dossiers in European Union, via national
procedures, MRS (Mutual Recognition Procedure) or DCP (DeCentralized
Procedure), in accordance with the particular projects and goals of
each customer. Responding without delay to the deficiency letters of
all European authorities is one important part of this activity, along
with providing to authorities all data related to the safety, efficacy
and quality of the product. Planning
and executing of the regulatory and marketing strategy until obtaining
of the Marketing Authorization shall be the main focuses of our teams.
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Regulatory affairs consulting and support
The expertise and experience of QPS’ partners and the open
comminication with each of our customers enables us to provide
proffessional consulting to anyone requiring it. In the same way, we
provide our regulatory support to our customer by preparing of the
documentation for renewals, variations, or pharmaceutical product legal
status switches in all European countries, as well as regulatory
support to post-submission regulatory issues.
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Regulatory strategy planning
The close colaboration with our customers in order to understand
their projects and their specific goals, gives us the possibility to
ellaborate a customised marketing and regulatory strategy planning for
their pharmaceutical products. This way our customers are adviced which
is the best registration procedure for a certain product on a certain
market, in terms of time-advantage and cost-effectiveness.
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