PVigi boasts a team of professionals well-versed in pharmacovigilance regulations and practices specific to the Turkish, Middle Eastern, and African regions. We prioritize compliance with local and international regulations, ensuring that our clients' pharmacovigilance activities meet stringent standards. Our expertise in navigating diverse regulatory landscapes minimizes risk and ensures the safety and efficacy of pharmaceutical products in these regions.
We understand that every client has unique needs and challenges. At PVigi, we offer personalized pharmacovigilance solutions designed to specific requirements. Leveraging cutting-edge technology and streamlined processes, we prioritize efficiency in our operations. Our goal is to optimize workflows, enhance data accuracy, and promptly address safety concerns, allowing our clients to focus on their core business while ensuring robust pharmacovigilance activities.
Operating in Turkey, the Middle East, and Africa, PVigi brings a deep understanding of the local market dynamics, cultures, and languages. Our regional focus allows us to provide tailored strategies that resonate with the diverse populations and regulatory nuances in these areas. Furthermore, our extensive network and established relationships within the healthcare ecosystem enable us to efficiently collaborate with local authorities, healthcare professionals, and stakeholders, fostering trust and facilitating seamless pharmacovigilance operations.
We offer full pharmacovigilance operation including QPPV, LQPPV, LCPPV etc in many areas.
PVigi performs market access operations & Regulatory approval of the product. PVigi also handles safety submissions (SUSARs, DSURs, SUSAR-LLs) to applicable Regulatory Authorities, Central Ethic Committees / Central Institutional Review Boards and to investigators. Other safety submissions may also be performed when required by the sponsor or by NCAs or CECs/CIRBs or by investigators in specific countries.
Regulatory and approval, Pricing, Market Access in Turkey and MENA Region. Any information about market and local regulation will be shared with experienced team
At Pvigi we offer global or local literature monitoring services which support signal management and inform the benefit-risk profile of drug safety process.
We gather and analyse of information on regulatory processes, requirements, and policies. It helps companies to understand the changing landscape of regulations and make informed decisions about their products.
We offer a spectrum of Medical Information Services delivered on a 24/7 basis by our bilingual native-speaking professionals.
Published Date: April 15, 2014 CHAPTER ONEPurpose, Scope, Basis and DefinitionsARTICLE 1 – (Amended:OG-21/7/2022-31899)(1) The purpose of this Regulation is to determine the procedures and principles regarding thesystematic monitoring of adverse reactions and benefit/risk balances, Read more…
Published Date: 15.07.2014 Table of Contents Chapter I. 2 Introduction. 2 1.1 Introduction. 2 Chapter II. 2 Structures and Processes. 2 2.1 Principles for assigning additional monitoring status to a medicinal product 2 2.2 Communication Read more…
APPENDIX I – Definitions Published Date: 12.06.2014Table of Contents EU Reference date, Union reference date. 3 Adverse event (AE), Adverse experience. 3 Adverse reaction, Adverse drug reaction (ADR), Suspected adverse (drug) reaction, Adverse effect, Undesirable Read more…