Regulatory services

Our team of professionals knows the local legislative requirements 

Dokumeds provides professional, practice-based regulatory consulting expertise and support throughout the product life-cycle. Services in pre-authorization and post-authorization phases, as well as medical affairs include:

Clinical trials 

  • Clinical trials applications
  • Regulatory submissions
  • Authorization maintenance and support

Marketing authorization

  • Marketing authorization applications, national and EU (Mutual Recognition Procedure, Decentralized Procedure)
  • Post-approval license maintenance

Other Services

  • Scientific and regulatory advice
  • Communication with authorities
  • Compilation and submission of reimbursement application and obtaining approvals
  • Pharmacoeconomic evaluations
  • Monitoring regulatory environment

In Russia and Ukraine Dokumeds’ services are supported by in-depth regulatory consultancy services. Our national-level know-how in Russia and Ukraine ensures our ability to handle country specific procedures while complying with local laws and requirements.