Our Services

Submitted by Dr. Kosta Cvijovic on Mon, 10/02/2017 - 17:21
Drug Safety Services

The services of Cvigilance include, but are not limited to:

- Pharmacovigilance Training

- Pharmacovigilance Audits

- Inspection preparation and support

- PV strategy development, quality and compliance

- Review and update of existing SOPs, writing of new SOPs or possibility to use our in-house SOPs

- Processing of clinical trial and post-marketing individual case safety reports (ICSRs) and medical device incidents globally from receipt to submission

- Possibility to use client ICSR database or Cvigilance's Aris Global (arisg) database

- Periodic reports (DSURs/PSURs/PBRERs/ASRs) preparation and submission globally

- RMPs and REMS preparation and Submission including management of complex risk management tools (aRMMs, ETASUs)

- EU QPPV function

- EudraVigilance registration and maintenance

- Safety Data Exchange Agreements (SDEAs)/Pharmacovigilance Agreements (PVAs) writing and assessment

- PV System Master File (PSMF) preparation and maintenance

- Signal detection and management

- Post-authorization safety studies (PASS), patient registries, compassionate use

- Literature search and Review, globally and locally

- Medical Information in different languages for Europe and North America

Please contact us for a free initial consultation at office@cvigilance.com or +43 660 50 13 13 2