A New Era in EU Pharmacovigilance: Changes and Our PharmaBASE Updates
This article covers the key changes introduced by Regulation ((EU) 2025/1466), which we have meticulously implemented for you.
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8/21/2025
End-to-End Pharmacovigilance and Regulatory Consulting
PharmaSoft provides expert consulting services in pharmacovigilance and regulatory compliance to companies operating in the pharmaceutical industry. We support you every step of the way, from case management and literature reviews to safety reporting and licensing processes. Our goal is not just to manage your processes, but to enable you to manage them more accurately, quickly, and securely.
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Active Substances
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Products
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Projects
Our team monitors, manages, and provides solutions for you
The PharmaSoft team works as a trusted advisory force behind the scenes for pharmaceutical companies in their pharmacovigilance and licensing processes. Regulatory monitoring, document preparation, notification processes, reporting, and operational controls are regularly carried out by our experts. This way, our clients don't have to single-handedly track what needs to be done and when in critical compliance processes.
Rabia Ayşe Çetin
Co-Founder & General Manager
Onur Can Toker
Business Development Manager
H. Aykut Yemenli
IT Manager
İlknur Bulut
Pharmacovigilance Manager
Our Digital Systems That Strengthen Our Consulting Services
Expert Support. Secure Systems. Traceable Processes.
PharmaSoft Suite is a family of digital solutions that makes the consulting services we offer in pharmacovigilance and licensing processes more secure, organized, and traceable.
With PharmaBASE, PharmaSEARCH, and DetectIO, we support you in managing your case management, literature review, signal tracking, and reporting processes more effectively with our expert team.
Become a Partner
Our Solutions That Combine Consulting with Technology
Digital Ecosystem
for Pharmacovigilance
PharmaSEARCH
Literature Search Platform
- Regularly monitor your local and global literature review processes
- Simplify your literature review, access reliable search results from a single platform
- Make literature review records reportable and auditable
PharmaBASE
Pharmacovigilance Database
- Manage your pharmacovigilance processes end-to-end with 14 integrated modules
- Monitor your E2B(R3), CIOMS, and TUFAM notification flows on a single platform
- Strengthen data integrity and process control in pharmacovigilance operations
DetectIO
Signal Detection Application
- Systematically evaluate potential signals in security data
- Support your signal management processes with data-driven analytics
- Gain stronger insights in risk monitoring and decision-making processes
Core Capabilities of Our Digital Pharmacovigilance Systems
Literature Review and NLP
It makes local and global literature review processes more traceable and efficient through AI-assisted classification.
Case and Report Management
The system manages the recording, tracking, and reporting workflows for adverse events, ICSR, PBRER/PSUR, and RMP processes in a single central location.
Compliance and Data Security
It offers a reliable infrastructure that supports TİTCK, EMA, MedDRA, e-signature, audit trail and GDPR requirements.
Open and Integrated Platform
API, SSO, export and shareable report dashboards make pharmacovigilance operations more connected.
Certified Excellence and Reliable Compliance
ISO/IEC 27001:2022
ISO 9001:2015
Certified PV Services Provider by Turkish MoH
Validated Solutions for Pharmacovigilance & Regulatory Affairs
From Data Integrity to Audit Transparency
We provide reliable data, traceable workflows, and audit-ready reporting in pharmacovigilance and licensing processes. We strengthen your company's operational control in the areas of drug safety, regulatory compliance, and digital process management.
- Simplify your pharmacovigilance and reporting processes
- Protect data integrity with a reliable digital infrastructure
- Ensure traceable and transparent record management in audit processes
Industry Leaders Trust Us
We support global pharmaceutical companies with validated software and compliance expertise.
Become a Partner
What do our business partners say?
We are not the best judges of our work; those who work alongside us do. Our valued business partners who work with PharmaSoft describe our meticulousness, transparent working methods, and solution-oriented approach through their own experiences. These sincere testimonials inspire us to provide even better service every day. At PharmaSoft, we prioritize creating long-term trust and benefits in every collaboration.
Solution-Oriented & Dynamic Approach
Dr. Pharm. Ömer Hulki OCAK
Director of Scientific Operations / NOBEL ILAC
"We would like to thank the valuable PharmaSoft family for their contribution to our company, thanks to their solution-oriented, reliable and dynamic approach; and we hope that our cooperation will continue in the coming years."
Dr. Pharm. Ömer Hulki OCAK
Director of Scientific Operations / NOBEL ILAC
PharmaText
Next Generation Technologies in the World of Pharmacovigilance and PharmaSoft
Digitalization in pharmacovigilance with PharmaSoft: Discover our secure, fast, and modern solutions with PharmaBASE and PharmaSEARCH.
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11/11/2022
Educational Content from Pharmacovigilance World
Useful content from the world of pharmacovigilance: Learn about drug safety with WHO trainings, TİTCK guidelines, and PharmaSoft Atelier videos.
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11/3/2022
Latest Events
Stay up-to-date with our global events and seminars designed to empower pharmacovigilance and regulatory professionals.
News from ISoP Seminar in Boston — Boston 2022
Join us to discover the next generation of pharmacovigilance technologies and meet our experts in person.
5-6 December 2022
Boston, USA
PharmaSoft ACADEMY
Stay up-to-date with our online training programs designed to empower pharmacovigilance and regulatory professionals.
Regulatory Affairs Essentials
A comprehensive e-learning module covering file preparation, EMA and TİTCK compliance.
12 September 2026
Online