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Clinical development

The Medone’s Research regulatory team provides support throughout the entire cycle of the clinical projects. We provide to our Sponsor’s with up-to-date Country Specific Guidelines for Regulatory activities as well as inside knowledge and strategy of submissions in CEE region.

  • Initial Applications
  • Amendments
  • Annual Safety Report (ASR) and Periodic Safety Update Report (PSUR)

Welcome to MEDONE!

01.

Our Services

Our extensive medical expertise, clinical research and regulatory experience are used to deliver our clients with superior quality services in each and every phase of the clinical trial.

03.

Medical Monitoring

Our extensive medical expertise, clinical research and regulatory experience are used to deliver our clients with superior quality services in each and every phase of the clinical trial.

05.

Consulancy

Our extensive medical expertise, clinical research and regulatory experience are used to deliver our clients with superior quality services in each and every phase of the clinical trial.

02.

Outsourcing

Our extensive medical expertise, clinical research and regulatory experience are used to deliver our clients with superior quality services in each and every phase of the clinical trial.

04.

Biostatistics|Medical Writing

Our extensive medical expertise, clinical research and regulatory experience are used to deliver our clients with superior quality services in each and every phase of the clinical trial.

Let’s Collaborate

Ready to
work with us?