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Prepare local documentation
for centralised, mutual recognition & national
registrations, variations and transfers
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Prepare pricing dossier and
advise on reimbursement in Italy
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Prepare clinical trial applications
to the local ethics committees, Ministry of Health, AIFA or Istituto
Superiore di Sanità
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Organise meetings with AIFA & the
Ministry of Health and make daily trips to AIFA to resolve problems
and pick-up/deposit documents
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Provide technical and regulatory assistance
for due diligence licensing & acquisition
activities
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Translation of technical documentation from
or into Italian Organisation of sworn translations
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Advice and aid on local pharmacovigilance
issue and requirements
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Advice on the preparation of labelling according
to national requirements
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Organising for various certificates and
licences (e.g. free sale certificates, GMP certificates, narcotic
licences)
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Organise for payment and publication of decrees
in the GU and organise for payment of fees on behalf of the client
