Aristotelesstraat 18, 1064 LD, Amsterdam
Street Victor Brauner no. 400, Bl. 1, Ap. 13, District 3, Bucharest, Romania
+31 (0) 629075858
info@regpakbiopharma.com
PHARMACOVIGILANCE

Providing Expertise in Vigilance since 2008

RegPak’s high quality consultancy services include Pharmacovigilance (PV) to ensure drug safety.

In recent years there has been an increased focus on Pharmacovigilance. Taken in conjunction with increasingly complex and demanding regulatory requirements, this means any product introduction requires complete and thorough knowledge as well rigorous adherence to approved processes to maintain compliance with worldwide Drug Safety/Pharmacovigilance obligations. RegPak’s global Pharmacovigilance services combined with specific consultancy and assistance throughout product development and marketing life cycle to meet client PV needs. The ultimate goal of pharmacovigilance is to appropriately handle information concerning adverse drug reactions and to protect the public from emerging safety issues throughout a medicine’s lifecycle

Our services include

Pharmacovigilance monitoring 24x7x365
Eudravigilance & MHRA Reporting 
EU & UK Qualified Person Responsible For Pharmacovigilance (QPPV), Deputy QPPV and  local QPPV Services globally 
literature monitoring
med info activities
Signal detection & risk assessment activities
Safety narrative writing
Safety data exchange agreement (SDEA) set-up
Electronic submission of product information to EMA database (XEVMPD)
Establishing in-house PV systems incl. SOP/Policy writing
Pharmacovigilance training
Global pharmacovigilance intelligence
pharmacovigilance Audits
Medical Writing Services
    • Risk Management Plan (RMP)
    • Risk Evaluation and Mitigation Strategy (REMS)
    • Company Core Data Sheet (CCDS)
    • Summary of Products Characteristics (SmPC)
    • Patient Information Leaflet (PIL)
    • Periodic Safety Updates (PSUR/PBRER)
    • Developmental Safety Update Report (DSUR)
    • Pharmacovigilance System Master File (PSMF)

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OUR EXPERTISE