"Only a professional partner makes your busines better!"

Regulatory Affairs

BioMedical Centrum provides adequate support for domestic and international companies (manufacturers and distributors) in various scientific and professional fields:

Regulatory Affairs and Consulting

  • Preparation, revise of dossiers, documentations
  • National procedures
  • Decentralized procedures (DCP), mutual recognition procedures (MRP)
  • Renewals, variations
  • Common Technical Document (CTD) preparation
  • Translation, adaptation of product information (SmPC, PIL, label texts)
  • Application for price reimbursement
  • Contact with authorities
  • Consultancy


Preparation/proofreading of literature and clinical descriptions or summaries
Preparation of expert opinions/judgments

In cooperation with our partners our services include:


Clinical trials

  • Regulatory Affairs
  • Feasibility and site selection
  • Clinical monitoring
  • Local project management



  • Local contact to Pharmacovigilance Department of the Regulatory Authority
  • Submission of PSURs, line listings, and local SUSAR reports
  • Submission of RMPs
  • Collection of adverse events from local literature
  • Collection of ICSRs / documentation
  • AE follow-up
  • PV training for clients’ personnel
  • Regulatory Authority’s communication
  • Reconciliation report