About
PharmaSoft

Since 2015, we’ve been delivering innovative, tailored solutions for the evolving needs of the pharmaceutical industry — with a flexible and dynamic approach.

Whether you manufacture in Türkiye and export globally, or produce abroad and aim to enter the Turkish market —
we manage all your pharmacovigilance and regulatory processes end-to-end.

🌍 And our reach doesn’t stop at national borders — we also offer global pharmacovigilance and regulatory services.

💻 Backed by a strong IT infrastructure and an expert team, we go beyond standard offerings to develop integrated, intelligent solutions tailored to your company’s unique needs.

Whether you’re looking for a system, a team, or simply the right direction — PharmaSoft is where solutions begin.

Yes. PharmaSoft is officially authorized by the Turkish Medicines and Medical Devices Agency (TİTCK) as a Contracted Pharmacovigilance Service Provider (CPSP).

This authorization grants us the right to legally and fully manage your pharmacovigilance responsibilities —
in full compliance with national regulations and always inspection-ready.

All our pharmacovigilance services are delivered in strict alignment with the current TİTCK guidelines.

As per regulatory requirements, we assign at least one pharmacist-qualified QPPV for every 100 active substances (molecules) in your portfolio — ensuring you have the appropriate number of qualified personnel and deputies in place.

To support these services, we use PharmaBASE, our in-house drug safety database, which offers:

📌 Full compliance with E2B(R3) standards

📌 Integrated MedDRA terminology

📌 A secure, transparent, and inspection-ready infrastructure

In short — everything you need for a technically sound and legally compliant pharmacovigilance service is right here.

With a certified, experienced, and digitally empowered team by your side — you’re in safe hands with PharmaSoft.

Yes. PharmaSoft is officially authorized by the Turkish Medicines and Medical Devices Agency (TİTCK) as a Contracted Pharmacovigilance Service Provider (CPSP), and this certification is regularly renewed.

Our consistent success in all TİTCK inspections conducted as part of certificate renewal procedures has ensured the continuity of our authorization — and we continue to operate with our most up-to-date certification.

You can verify our current certification date on TİTCK’s official website:

🔗 CPSP Certification List – TİTCK (April 2025)

Yes. According to Turkish regulations, pharmaceutical companies can outsource pharmacovigilance (PV) services to organizations that are officially authorized by the Turkish Medicines and Medical Devices Agency (TİTCK) as a Contracted Pharmacovigilance Service Provider (CPSP).

As a certified CPSP, PharmaSoft is legally authorized to act as your local pharmacovigilance department in Türkiye, assuming full pharmacovigilance responsibilities on your behalf in full compliance with national requirements.

This includes:

• Establishing the local PV system

• Appointing the local QPPV and deputy based on product count

• Using an E2B(R3)-compliant, MedDRA-integrated safety database

• Conducting weekly local and global literature screening

• Managing ADR reporting

• Coordinating with TMMDA (local competent authority) and maintaining all required documentation

In addition, we also provide project-based support for companies that already have an in-house PV team:

✅ Weekly local and global literature screening

✅ Preparation of Periodic Benefit/Risk Evaluation Reports (PBRER)

✅ Preparation of Risk Management Plans (RMPs)

✅ Preparation of Addendum to Clinical Overview (AddCo)

✅ Compilation and updates of the Pharmacovigilance System Master File (PSMF)

✅ Daily safety signal monitoring

✅ Mock audits

✅ CAPA preparation and management

✅ ADR case management

Whether you’re seeking a full-service PV partner or need targeted support in Türkiye, PharmaSoft is here to help — compliant, reliable, and always audit-ready.

According to current regulations issued by the Turkish Medicines and Medical Devices Agency (TMMDA), all Marketing Authorization Holders (MAHs) in Türkiye are required to appoint the following three roles:

🔹 Qualified Person Responsible for Pharmacovigilance (QPPV)

🔹 Deputy QPPV

🔹 Contact Person (for liaison with the TMMDA and the CPSP)

The QPPV and Deputy QPPV must be pharmacists or physicians residing in Türkiye. These roles may be fulfilled by personnel within the MAH’s organization or assigned via an authorized Contracted Pharmacovigilance Service Provider (CPSP) such as PharmaSoft.

The Contact Person, on the other hand, must be designated from within the MAH’s own organization.

This role does not require a specific professional background, but the individual must be knowledgeable and competent in pharmacovigilance matters and responsible for maintaining communication between the TİTCK and the CPSP.

PharmaSoft, as a certified CPSP:

✅ Provides QPPVs and deputies based on your product portfolio size

✅ Ensures all responsibilities are fulfilled in accordance with current legislation and guidance

✅ Builds and maintains inspection-ready, compliant PV systems tailored to your needs

If you are seeking a trusted local partner in Türkiye to ensure full compliance with pharmacovigilance obligations — PharmaSoft is here to support you.

In Türkiye, pharmacovigilance activities are regulated and supervised by the Turkish Medicines and Medical Devices Agency (TMMDA), under the authority of the Ministry of Health.

All pharmacovigilance-related processes are managed by four main units operating under the Department of Pharmacovigilance and Controlled Substances:

1. Turkish Pharmacovigilance Center (TÜFAM)

• Collects and evaluates adverse reaction reports; encodes them using MedDRA and forwards to the WHO database.

• Forwards serious ADR reports submitted by healthcare professionals or consumers directly to the marketing authorization holder (MAH).

• Investigates potential safety issues arising from ADRs.

• Provides training and awareness programs for QPPVs, their deputies, and contact points across the country.

2. Pharmacovigilance Risk Management Unit

• Monitors safety alerts from global health authorities and evaluates their local impact.

• Reviews and assesses Risk Management Plans (RMPs) and Periodic Benefit-Risk Evaluation Reports (PBRERs).

• Prepares and updates additional monitoring lists.

• Maintains the registry of QPPVs and deputies, and organizes relevant training activities.

3. Narcotic and Psychotropic Substances Control Unit

• Oversees the import, export, and controlled distribution of narcotic and psychotropic drugs.

• Monitors potential abuse and ensures compliance with prescription regulations (e.g., red and green prescription books).

4. Precursor Control Unit

• Regulates the legal trade of precursor chemicals that may be used in illicit drug production.

• Coordinates with national and international stakeholders to prevent misuse or illegal trafficking of chemical substances.

Together, these units ensure that Türkiye’s pharmacovigilance system operates in compliance with international standards and remains continuously audit-ready.

Yes. For companies without a local affiliate in Türkiye, PharmaSoft provides full regulatory support — from pre-submission strategy development to successful dossier approval.

Our regulatory affairs team is composed of experienced professionals who are well-versed in national and EU regulatory frameworks, fully proficient in e-CTD technical requirements, and actively engaged in Türkiye’s electronic submission platforms.

Our services include:

🔹 Regulatory strategy development

– Determining the optimal application pathway (original, generic, hybrid, traditional, etc.)

– Assessing requirements based on dosage form, product type, and applicant status

🔹 e-CTD dossier preparation

– Complete authoring of Modules 1–5 in line with CTD structure

– Document formatting, dossier compilation, and hyperlinking

– XML backbone creation and validation checks using compliant tools

🔹 Preparation and revision of SmPC and PIL

– Translation and adaptation to QRD format

– Ensuring alignment with the Turkish guidelines and readability standards

🔹 Variation submissions

– Classification of Type IA/IB and Type II variations

– Regulatory impact assessment

– Timely submission and follow-up with authorities

🔹 Renewal applications

– Evaluation of expiring MA licenses and preparation of updated documentation

– Gap analysis and preparation of deficiency responses

🔹 Special product categories

– Traditional Herbal Medicinal Products

– Food Supplements (including active ingredient verification and efficacy support)

– Biocidal Products

– Veterinary Medicinal Products (VMPs), prepared in line with dedicated regulatory frameworks

PharmaSoft is not just a technical dossier service provider — we act as your strategic partner, anticipating authority expectations, navigating local nuances, and ensuring that your registration process is proactive, compliant, and inspection-ready.

If you want a confident and seamless entry into the Turkish market — PharmaSoft is here to lead the way.

At PharmaSoft, we not only use our proprietary applications to deliver regulatory and pharmacovigilance services —
we also offer these tools to our clients as Software as a Service (SaaS) solutions.

Through SaaS licensing, clients can securely access our validated, cloud-based systems such as PharmaBASE, PharmaSEARCH, and Detectio, benefiting from:

✅ Continuous feature updates

✅ Secure data storage and backup

✅ Regulatory-compliant infrastructure

✅ User-specific dashboards and filters

✅ 24/7 access without local installation

For companies seeking deeper customization, PharmaSoft also offers Platform as a Service (PaaS) options.

This allows our applications to be integrated directly into your internal IT infrastructure, enabling seamless interoperability with existing workflows, databases, and business platforms.

Whether you prefer out-of-the-box use or API-level integration, PharmaSoft’s modular digital architecture adapts to your technical needs — securely, flexibly, and with full regulatory compliance.

At PharmaSoft, we develop tailor-made digital tools to streamline pharmacovigilance and regulatory workflows for the pharmaceutical industry — with a strong focus on compliance, traceability, and efficiency.

Our current product suite includes:

💠 PharmaBASE

A regulatory-compliant pharmacovigilance database designed for E2B(R3) reporting, fully integrated with MedDRA and WHO-Drug dictionaries. Supports secure archiving, advanced querying, and audit-ready reporting.

💠 PharmaSEARCH

A smart literature screening tool covering over 600 scientific journals, offering configurable keyword-based search, summary notes written by experts, and traceable archiving for inspection readiness.

💠 DetectIO

An AI-powered signal detection platform trained on 10 years of FDA data, utilizing machine learning models to identify potential safety signals and track time-based trends across drug-event pairs.

These systems are available not only as part of our service packages, but also through Software as a Service (SaaS) or Platform as a Service (PaaS) licensing models.

All PharmaSoft applications are:

✅ Designed for seamless integration with your internal systems (via database sync, API, or user interface level)

✅ Flexible, with role-based access and workflow customization

✅ Fully compliant with GxP and inspection-ready architecture

In addition, we design and implement custom Robotic Process Automations (RPAs) to support high-volume, repetitive operations across platforms — including data transfers, reporting automation, document processing, and system interactions.

PharmaSoft digital solutions combine speed, safety, and regulatory alignment — empowering pharmaceutical operations for the future.