Our firm provides judicial and extra-judicial assistance in the pharmaceutical field, with reference to both human and veterinary products. Our pharmaceutical practice includes:
- Pharmaceutical manufacturing and related regulatory and administrative profiles;
- Drug registration process;
- Marketing authorisations for medicinal products (national, international and EU procedures) and related regulatory aspects;
- Co-marketing, licensing, transfer of national and international Marketing Authorisation;
- Risk management and organisational model pursuant to Italian legislation;
- Industrial property;
- National and international contracts (confidentiality and non-disclosure agreements, research and development contracts, supply contracts, distribution agreements, licensing agreements);
- Customs law;
- Assistance for disputes before all civil and administrative jurisdictions, in Italy and internationally.
We ensure that our clients are in full compliance with Italian, EU and international pharmaceutical legislation, as well as with the guidelines published by pharmaceutical authorities, such as the European Medicines Agency (EMA), the International Council on Harmonisation (ICH) and the World Health Organisation (WHO).