Our services

Dr. Müller Pharma is the largest independent manufacturer of medicinal products, medical devices, cosmetics, and food supplements in the Czech Republic.

Regulatory Affairs & Pharmacovigilance

Our Regulatory Affairs team provides critical regulatory guidance at every step of the product development process, from Marketing Authorisation Application to full product life-cycle:


  • Regulatory strategy for medicinal products, medical devices, food supplements, cosmetics and food.
  • Product Life-cycle management support:
    • Marketing Authorisation Applications, Variations, Notifications, Renewals, other European procedures, etc.
    • Medical and Scientific Writing
    • CMC regulatory strategy
    • eCTD compilation and submission support
    • Readability Testing
    • Global Labelling management
    • Update of Medical Device TechFiles according to the requirements of MDR
  • Pharmacovigilance consulting services:
    • SDEA development and maintenance
    • PhV systems management
    • Services of EU QPPV and/or Deputy QPPV
    • EudraVigilance and XEVMPD support
    • Signal and Benefit/Risk management
    • Third party Pharmacovigilance audits
    • Pharmacovigilance trainings
    • ICSR/Cases Management
    • CAPA Management
    • SOP writing and maintenance
    • Vigilance of medical devices


Portfolio of medical devices (in line with current MDR):

  • glycerine suppositories
  • water-based lubricant gels
  • silicone-based lubricant gels
  • lubricant gel with hyaluronic acid
  • vaginal gel with hyaluronic acid
  • vaginal suppositories with hyaluronic acid
  • nasal sprays with aloe vera or magnesium
  • lice lotion
  • hard-boiled sugar lozenges
  • hard-boiled sugar-free lozenges
  • oral sprays