Healthcare Regulatory Compliance

Growing value of healthcare in modern life has had its imminent impact on the related regulatory regimes and administrative procedures with their constantly increasing complexity and public importance.
We are aiming at the provision of solution oriented and business efficient advice and assistance on:

  • Market authorizations and pricing regulations proceedings and problems.
    We can advise you on any of your cases in the procedures of pricing reference as well as building your defense strategy in keeping the official prices in force. We can also represent you in front of Transparency Committee and Administrative Court in matters related to pricing.
  • Representation before the competent public bodies.
    Support in local negotiation procedures with healthcare stakeholders. We can structure the launch path for your products, support you on building stakeholders’ map and outlining the critical processes for getting access to effective national reimbursement. We are capable to provide you professional advice for your contracts with state bodies (payers, hospitals and ect.).
  • Market access consultancy for building your positioning strategy and ensuring access to patients. Support in local negotiation procedures with healthcare stakeholders.
  • IP, competition and consumer protection aspects and specifics of the business with pharmaceutical products.