Pharmaceutical business is one of the most challenging industries in the world. With an evolving regulatory landscape; competition threatened by alternative generics; intellectual property disputes or parallel trading; drug companies are facing pressure from all directions. Our colleagues have in depth experience in dealing with regulatory frameworks, preparing compliance policies, handling registrations of drugs and obtaining licenses.
Selected recent references:
(H) Representing a Danish distributor of drugs in regular audits in front of the Hungarian National Institute of Pharmacy
(H) Advising a US drug manufacturer in creating its European shared service centre
(CZ) long-term advice with corporate matters and medicine law for one of the biggest US drug manufacturers