Regulatory Affairs 
and Pharmacovigilance Services

  • Registration of pharmaceutical products through National, Mutual Recognition and Decentralised procedures
  • Maintenance of the Marketing Authorisations through variations and renewals
  • Preparation and submission of Pricing and Reimbursement applications
  • Effective deals with the authorities and intensive follow-up in every submission, in order to ensure timely conclusion of the national phase of the procedures
  • High quality translations of the Summaries of Product Characteristics, Labeling and Patient Leaflet to the local language
  • Consultancy services concerning the local regulatory provisions and requirements.
  • Training in Regulatory Affairs
  • Set up and implementation of Pharmacovigilance System
  • Collection, Assessment and Reporting of Adverse Events (AEs) originating from clinical trials or other organised data collection systems, spontaneous reports or literature.
  • Local Literature review

We deliver high quality services 

in the Czech and Slovak Republics.

We put our emphasis on quality, experience, credibility and flexibility.

We invite you to consider our services and to contact us to discuss your clinical trial and pharmaceutical needs.