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EU Pharmacovigilance local contact services
EU Pharmacovigilance local contact services case study. Small biopharmaceutical company with one pharmaceutical product authorized through a Decentralized Procedure in 10 European countries. The Client has all PV local activities outsourced to different vendors in each country, which poses several challenges.
Marketing Authorization Expansion in Europe
A case study about Marketing Authorization Expansion in Europe. A small European Pharmaceutical company with local activity in its country, with a growth strategy aiming to expand to international markets but lacking experience and capability in managing complex EU procedures.