Regulatory services 

Regulatory services cover all areas related to the regulation and management of medicines and medical devices. We work with both pharmaceutical clients and regulatory authorities to ensure that all processes related to the regulation of therapeutic substances are carried out in accordance with local or regional laws. Our team of experts is available for both long- and short-term assignments to provide our clients with the highest quality service in the market.

We offer our clients a comprehensive list of services in the following regulatory areas:

  • IVDR (In Vitro Diagnostic Medical Devices Regulation)
  • Regulatory strategy
  • Pharmacovigilance
  • Regulatory compliance  
  • Medical Device Regulation (MDR)
  • Clinical Trial Regulation (CTR)
  • Surgeries in clinical studies
  • Market entry of medicines

Contact us

Věra Valešová

Věra Valešová

Senior Manager

Věra focuses on themes related to GxP compliance, automation in pharmacovigilance and the implementation of electronic clinical databases. She studied neuroscience and has over 10 years of experience.... More