At Billev Pharma ApS we have a team of highly qualified PV employees with expertise in all aspects of pharmacovigilance. We offer services both within human and veterinary pharmacovigilance and provide flexibility whether a short-term or long-term solution is needed.
We offer services within:
- QPPV and 24/7 availability for human and veterinary pharmacovigilance
- PV QMS System
- Pharmacovigilance System Master File (preparation & maintenance)
- Risk Management Plan
- Handling of adverse drug reactions (collection, processing, distribution & reporting)
- Literature screening (Worldwide, MLM & local)
- Signal management
- Periodic Safety Update Reports
- Eudravigilance – reporting of adverse drug reactions
- XEVMPD – inserts and maintenance of product information
- Pharmacovigilance agreements / safety data exchange agreements
- Pharmacovigilance audits
- Support in connection with pharmacovigilance inspections
Services
Registration
We are well-equipped to provide regulatory advice, discuss strategy and/or compile the registration dossier.
Pharmacovigilance
We have a team of highly qualified pharmacovigilance employees with expertise in all aspects of pharmacovigilance.
Translations
We offer high quality medical & pharmaceutical translations into and from several European languages.
Electronic submission
We are equipped to assist with any type of electronic submission and maintenance of your electronic file.
Special medicines areas
Herbal medicinal products, strong vitamin and mineral products, medicinal gasses, euphoriant substances, etc.
GDP & GMP Services
We offer full time and part time responsible person (RP) function and qualified person (QP) function.
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