Are you seeking for assistance in complying with pharmacovigilance legislation or implementing a quality system?
Do you need an extra pair of 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 services supporting your pharmacovigilance department
Establishment and maintenance of pharmacovigilance systems
- Maintaining the pharmacovigilance system of your products throughout their entire life cycle.
- Case management: processing of product safety information on your behalf, including:
- Maintaining the product safety register
- Electronical processing (incl. MedDRA coding) and reporting electronically
- Providing medical evaluation and signalling (risk-benefit evaluation)
- Narrative writing.
- Literature surveillance and review (locally and internationally published in the Nordic and Baltic countries)
- 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
- Acting as your local safety contact towards authorities in the Nordic and Baltic countries
Good Pharmacovigilance Practices (GVP)
Our experts will plan and establish an effective pharmacovigilance quality system for your company including pharmacovigilance system master files (PSMF), standard operating procedures (SOP), annual internal audits, annual pharmacovigilance training and orientation training.
Registration and maintenance of EudraVigilance data
Our qualified and certified staff help you with registering 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).