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
Medicines
- 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
Pharmacovigilance
- 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
