Pharmaceuticals and healthcare
PROCTOR supports manufacturers and importers of medicines, distributors, pharmacy chains, private clinics and laboratories. This is a hyper-regulated industry: state registration of medicines and medical devices, licensing and GMP/GDP, advertising and promotion of medicines, public procurement by the Ministry of Health, clinical trials and medical practice.
Why PROCTOR
In pharmaceuticals there are no "minor" regulatory matters: a mistake in a registration dossier, a promotional material or tender documentation blocks the circulation of a product for months. PROCTOR combines regulatory expertise (the State Expert Centre, the State Medicines Service, the Ministry of Health) with anti-corruption compliance in dealings with doctors and with defence in inspections and criminal proceedings.
We support clients of the pharmaceutical market throughout the whole life cycle of a product, from clinical trials and registration to procurement, pharmacovigilance and disputes. It is for pharmaceutical companies and enterprise clients that the premium level service model of PROCTOR has been built.
Lines of work
- Registration of medicines and medical devicesState registration of medicines, amendments to registration materials, conformity assessment of medical devices, dealings with the State Expert Centre and the State Medicines Service.
- Licensing and GxPLicences for the manufacture and the wholesale and retail trade in medicines, GMP/GDP compliance, support of inspections.
- Advertising and promotion of medicinesLegal review of advertising materials and promotional activities, dealings with doctors (anti-corruption restrictions), circulation of OTC and Rx medicines.
- Public procurement of medicinesParticipation in procurement by the Ministry of Health and procurement agencies, challenging tenders, managed access agreements, reference pricing.
- Clinical trialsContracts for conducting clinical trials, insurance of patients, protection of trial data, ethics committees.
- Medical practiceLicensing of medical practice, contracts with the National Health Service of Ukraine, medical errors and disputes with patients, circulation of medical data.
Practices for the industry
The teams of PROCTOR that run matters in this sector.
Competition law and government relations (GR)A practice for companies whose main risk comes from the state as regulator: merger clearances and investigations by the Antimonopoly Committee of Ukraine, support during inspections and defence against administrative pressure, and, as a premium layer on top, influence over the rules of the game through lawmaking and advocacy.
Corporate law and M&AThe flagship transactional practice: the legal foundation for owning, running and selling a business. It covers M&A deals, corporate structuring and the protection of owners' interests, together with adjacent areas - employment relations with staff and senior management, and the personal wealth matters of business owners (private clients).
Customs law and international tradeA single product for importers and exporters: from structuring the foreign trade contract to defence against adjustments of the customs value. One client context - goods crossing the border.
Intellectual property and data protectionProtection of the intangible assets of a business: brands, technology, content and trade secrets - plus the lawfulness of personal data processing and legal readiness for cyber incidents. A natural pair for technology and consumer companies.
Tax practiceA standalone practice with the strongest lead generation potential: protecting a business from additional tax assessments, blocked tax invoices and pressure from the tax authorities, together with the lawful optimisation of the tax burden.
Clients from the industry
