PharmaSoft
at a glance

We have been providing innovative solutions for your business needs with our flexible and dynamic business model since 2015.

We provide end-to-end regulatory affairs and pharmacovigilance services to all pharmaceutical companies that want to manufacture their drugs in Turkey and sell their drugs abroad, or to manufacture abroad and sell their drugs in Turkey.

We also offer pharmacovigilance and regulatory affairs services globally.

With our expert IT staff, we offer tailored solutions in line with your business needs in pharmacovigilance and regulatory affairs.

PharmaSoft has been certified as the Contracted Pharmacovigilance Services Provider (CPSP) by the Republic of Turkey Ministry of Health.

In line with this authorization, as your pharmacovigilance department, we can fulfil all your pharmacovigilance responsibilities on behalf of you.

PharmaSoft’s Contracted Pharmacovigilance Services Provider (CPSP) certificate was renewed by the Turkish Medicines and Medical Devices Agency Inspection Unit for Good Pharmacovigilance Practices on 18 January 2020.

As an organization approved by the Republic of Turkey Ministry of Health, we can act locally as your pharmacovigilance department and we can fulfil all your pharmacovigilance responsibilities on your behalf.

We also provide the following services on a project basis for pharmaceutical companies with an in-house pharmacovigilance department:

✅ Weekly local and global literature review
✅ Periodic benefit-risk evaluation report (PBRER) preparation
✅ Periodic safety update report (PSUR) preparation
✅ Risk management plan (RMP) preparation
✅ ACO (AddCo) preparation
✅ Pharmacovigilance system master file (PSMF) preparation / update
✅ Daily monitoring of safety warnings
✅ Mock-audits
✅ CAPA preparation / CAPA management
✅ Adverse Drug Reaction (ADR) management

In line with the current PV regulation marketing authorization holders in Turkey are obliged to appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) and a Deputy QPPV who reside at the national level.

In accordance with the regulation, marketing authorization holders can outsource their responsibilities by assigning the QPPV and Deputy QPPV within Contracted Pharmacovigilance Services Provider (CPSP) by outsourcing their PV responsibilities to the CPSP.

In this sense, PharmaSoft is an approved organization that you can outsource your PV responsibilities.

Republic of Turkey Ministry of Health, Turkish Medicines and Medical Devices Agency (TMMDA), Pharmacovigilance and Controlled Substances Department.

Turkish Pharmacovigilance Center (TÜFAM), under TMMDA, is the only authorized government agency in Turkey responsible for the collection of spontaneous adverse reactions from healthcare professionals, patients and marketing  authorization holders.

We provide consultancy services in the field of regulatory affairs with our experienced staff. We manage the registration process in Turkey on your behalf. In this sense, PharmaSoft successfully carries out your license application processes by preparing your registration dossiers with its experienced regulatory affairs team.

Our regulatory affairs consultancy services include the following:

✅ Preparation of e-CTD registration dossier
✅ SPC & PIL preparation and revision
✅ Preparation of variation dossier
✅ Preparation of license renewal dossier
✅ Traditional Herbal Medicinal Product
✅ Food Supplement
✅ Biocidal Products
✅ Veterinary Medical Product

As PharmaSoft, we provide services using our own software, and we can also rent our software to companies as SaaS. In addition, companies rent our applications as PaaS and integrate them with their own systems.

We develop applications for the pharmaceutical industry that will help you in your digital journey in line with your business needs. We provide integration of these applications with your existing systems.

We can develop and implement RPAs for inter-application and/or bulk processes in the fields of pharmacovigilance and registration.