Industries
Pharma & Healthcare
Health is the most regulated of fields, where the cost of error is measured in more than money. We carry pharma and medicine through the regulatory maze.
Pharmaceuticals and medicine live under the closest regulatory watch, and in recent years its logic has moved quickly toward the European: the harmonisation of registration requirements, the recognition of good-manufacturing-practice inspections and the reform of public procurement of medicines through a central agency have changed the terms of market access. The war has sharpened the questions of uninterrupted supply, humanitarian import and the circulation of controlled substances.
We carry medicines and medical devices through registration, regulatory approval and market access, and we support distribution and licence agreements, participation in public procurement and the protection of intellectual property in molecules and brands. Marketing practices, dealings with physicians and the processing of patients’ health data we build within bounds where the regulator leaves no room for improvisation.
Related practice areas
- Pharma & Healthcare Registration of medicines and medical devices, regulatory approval and market access in a closely governed sector.
- Intellectual Property Trademarks, patents, copyright and trade secrets — portfolio strategy and enforcement against infringement.
- Public Procurement & PPP Support of public procurement and tenders in Prozorro, challenges before the AMCU, public-private partnerships and concessions.
- Competition & Antitrust Merger clearance, abuse of dominance and unfair competition — support in proceedings before the Antimonopoly Committee (AMCU).
- Data Protection Data protection under Ukrainian law and the GDPR — policies, data-processing agreements and handling of data-subject relations.
Introductions are made by referral and by enquiry alike. Tell us the matter; we will tell you plainly whether it is one for us, and how we would proceed.