On this page you will have an overview of our different services. Find the optimal solution for the specific needs of your company.

Area: EU (EMA) ● US (FDA)

  • Regulatory Affairs - Products

    • Medicinal Products

      • NCE/ Generics ● Biologics/ Biosimilars ● ATMP
      • Phytopharmaceuticals ● Homeopathics/Anthroposophics

    • Medical Devices

  • Regulatory Affairs - Clinical Trial Applications

We offer you

  • Interims-Management
    Temporary replacement of important employees in the area of Regulatory Affairs ● Support of companies in regard to complex projects or critical business processes ● RA Expert Recruitement
  • Pre-Approval Support
    Development ● Strategic Consulting ● Scientific Advice ● Briefing Package ● Submission Project
  • Post Approval Support
    Life Cycle Management/ Strategy (Line Extension) ● Maintenance (Variations, PSUR/PBRER, Renewal, Sunset Clause Monitoring)
  • Labelling Support
  • Regulatory Intelligence
  • Technical Writing
  • Medical Writing
  • Issue of eCTD-Dossiers
  • eSubmission (eCTD, NeeS, CESP, PharmNetBund)
  • EU-/ US-Network

Regulatory Affairs Network

Benefit from our expert network. Due to the collaboration of the following companies, we are able to use these synergies for your success.