What we do

Step-Wiser offers you its unique and integrated blend of services in healthcare business consulting organised in three steps:

  • First steps: establishing your business in Belgium or in Europe
  • Next steps: expanding your existing business and revitalising your organisation and projects
  • Step up: ad hoc services in the broad field of Healthcare, from strategy to launch

The service areas include a broad range of services in healthcare business consulting, among which for instance:

  • Foresight and strategy development: preparing your company, portfolio and product for the future in the Belgian and European context
  • Implementation plan development and support to execution
  • Market access advice and support for medicinal products (general approach, pricing, reimbursement, choice of packaging, dosage)
  • Medical affairs, including strategic support during clinical development of medicinal products
  • Quality assurance support including Total Quality Management, best practice manuals, site master file, SOPs, batch release, internal & external audits, training
  • Vigilance, including – Pharmaco-Materio-Nutri, EU Qualified Person, Pharmacovigilance System Master File, SOPs, PSUR/RMP/RMA writing, Literature Screening, RSI Management, ICSR Management, 24/7 call service, Internal & External Audits, Training
  • Public and regulatory affairs, including legal regulatory support, regulatory advice, license and product applications, clinical trial applications, variations, renewals
  • Innovation process support
  • Stakeholder mapping, analysis and multi-stakeholder engagement
  • Representation of your company with authorities, political decision makers, key opinion leaders at Belgian and European level
  • Negotiation, alliance formation, conflict management and facilitation advice and support
  • Communication, information and publicity, including Qualified Person I&P, Medical Information, Conformity Statements, Promotional Material Management, Sample Management
  • Translations of leaflets, labels, expert reports, medical/pharmaceutical/scientific texts in various EU languages
  • … and many more!