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Strategic regulatory
advice
Marketing authorization
applications
Variation applications
and line extensions
Liaison with
regulatory authorities
Conversion into
CTD
Updating of
dossiers
Orphan Drug
designation
Evaluation for
in-licensing
Regulatory intelligence
SmPC´s
and patient leaflets
Scientific
advice
SME
Paediatric
Related services
Top ˆ
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Updating of dossiers
It is recommended to regularly update the dossier and expert
reports (summaries and overviews) with the responses to the
questions generated during the regulatory review procedure,
as well as to incorporate all variations. This will allow the
submission of a consolidated dossier in other countries that
accept EU style dossiers, as well as maintain an overview for
the company of the exact procedures and specifications registered.
In many companies, updating a dossier is not considered a high
priority task, and it can be easily outsourced.
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