By RegPak BioPharma…
RegPak’s Pharmacovigilance & Drug Safety Services
RegPak BioPharma Consulting (RegPak) offers high quality consultancy services allowing clients to concentrate on other aspects of their businesses.
Amongst various other services that RegPak offers, is a suite of Pharmacovigilance (PV) services needed to ensure drug safety. These offering include drug safety services, such as collection, detection, assessment, monitoring and prevention of adverse effects with pharmaceutical products.
In recent years there has been an increased focus on Drug Safety and 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.
Pharmacovigilance service features
RegPak’s global Drug Safety/Pharmacovigilance services combined with specific consultancy and assistance throughout product development and marketing life cycle to meet client PV needs.
Features of the service include:
- Pharmacovigilance monitoring of the products 24/7/365:
- Acting as Qualified Person Responsible For Pharmacovigilance (QPPV), Deputy QPPV and providing local QPPV Services globally as applicable
- Local literature monitoring incl. med info activities
- Electronic submission of Adverse Drug Reactions/Adverse Events (ADRs/AEs) to European Medicines Agency (EMA), US Food & Drug Administration (FDA) and other regulatory agencies worldwide
- 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
Medical / Regulatory Writing Services
RegPak covers various medical writing needs of companies. These include:
- Clinical Development Plans (CDPs)
- Risk Management Plan (RMP)
- Clinical Study Protocol (CSP)
- Risk Evaluation and Mitigation Strategy (REMS)
- Summary of Products Characteristics (SmPC)
- Patient Information Leaflet (PIL)
- Periodic Safety Updates (PSUR/PBRER)
- Pharmacovigilance System Master File (PSMF)
- Investigators Brochure (IB)
- Pediatric Investigational Plans (PIP)
- Orphan Drug Applications
- Company Core Data Sheet (CCDS)
- Target Product Profile (TPP)
- Prevalence & Epidemiology Reports