Medical Dossier Review and Optimization:
Having identified through portfolio evaluation products that would
be appropriate in the countries of the EU , MMA review existing
regulatory product dossiers in order identify the completeness of
these documents for EU approval submissions, either on an individual
country or mutual recognition process.
Where deficiencies are identified by MMA, we advise on the ideal
method and time scale and cost for the optimization of the deficient
dossier, and then manage the upgrading or updating process on behalf
of the client. This is particularly relevant where language issues
are of primary concern.
|
