Seeking for assistance in complying with pharmacovigilance legislation or implementing the quality system? Do you need extra hands to handle all your reporting needs? Are you lacking a Qualified Person for Pharmacovigilance (QPPV), a Local Drug Safety Officer (LDSO) or a Medical Advisor?
Our pharmacovigilance services are available throughout the EU and all Nordic and Baltic markets.
Establishment and maintenance of pharmacovigilance systems
- Maintaining the pharmacovigilance system of your products throughout the entire life cycle.
- Case Management: the processing of product safety information on your behalf, including:
- maintaining the product safety register
- processing (incl. MedDRA coding) and reporting electronically
- providing medical evaluation and signalling (risk-benefit evaluation)
- archiving documents appropriately
- narrative writing.
- Literature surveillance and review: literature published internationally (Medline), locally and documentation / processing Medical Literature Screening results in case of your product safety information
- Medical writing: compiling and maintaining any required pharmacovigilance documentation, including:
- Pharmacovigilance System Master Files (PSMF)
- Periodic Safety Update Reports (PSUR) in PBREP format
- Risk Management Plans (RMP)
- Clinical Overviews
- Signal Detection (risk-benefit evaluation)
- Regulatory Intelligence – keep up to date with regulatory guidelines and amendments to legislation
- Contact towards authorities on your behalf
Good pharmacovigilance practices (GVP)
Our experts can plan and establish an effective pharmacovigilance quality system for your company that includes Pharmacovigilance System Master Files (PSMF), Standard Operating Procedures (SOP), annual internal audits, annual pharmacovigilance training and orientation training. We can also supply guidelines for planning pharmacovigilance quality indicators and monitoring compliance.
Registration and maintenance of eudravigilance data
Our qualified and certified staff can help registration and maintaining your data in the EVWEB electronic database of the European Medicines Agency, for example by registering your products in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) and making sure the information is kept up to date. In addition, we can handle the Electronic Transmission of Individual Case Safety Reports (E2B).
We provide advanced training and mentoring for experienced experts, as well as orientation training for new experts for handling registration tasks. We also offer an innovative approach to annual training events, as well as pharmacovigilance training for new employees.
We offer expert medical translation services in all languages – fast and flexibly!