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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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Paediatric
The paediatric regulation, which came into force on 26 January
2007, requires all new product applications to include a paediatric
investigation plan (PIP) for the development of the product
in children. If the product is for conditions that do not affect
children, or would be ineffective or unsafe in children, the
sponsor can request a waiver from the requirement. In addition,
there are compounds for which it can be justified to first complete
development in adults before investigating in children, and
hence request a deferral. Dorian Regulatory Affairs BV can assist
with ensuring compliance with the paediatric regulation.
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