Contracted Pharmacovigilance
Services Provider
As part of the certification inspection conducted by the Agency (TMMDA);
✅ all our business processes,
✅ Our PharmaBASE pharmacovigilance database,
✅ Our PharmaSEARCH literature review application
have been approved in terms of quality and effectiveness.
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RMP & ACO (AddCo)
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PSUR & PBRER
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PSMF
Pharmacovigilance
Reports
PharmaSoft manages the following processes for all reports prepared by its team of experts and delivers high-quality outputs resulting in administrative authority approval.
✅ Comprehensive literature review and detailed research
✅ Administrative authority standards (TMMDA & EMA)
✅ Up-to-date templates in accordance with administrative authority (TMMDA & EMA) standards
✅ Case analyses
✅ Functional exposure calculation
✅ Cumulative spreadsheets
✅ Error proofing effective quality control system
✅ Comprehensive literature review and detailed research
✅ Administrative authority standards (TMMDA & EMA)
✅ Up-to-date templates in accordance with administrative authority (TMMDA & EMA) standards
✅ Case analyses
✅ Functional exposure calculation
✅ Cumulative spreadsheets
✅ Error proofing effective quality control system
Pharmacovigilance
Department Services
As a Contracted Pharmacovigilance Services Provider, we undertake all your pharmacovigilance responsibilities.
We manage your pharmacovigilance processes within the framework of up-to-date regulation and good pharmacovigilance practices.
We ensure business continuity with a quality and effective service and pursue your pharmacovigilance liabilities uninterruptedly on behalf of you.
We manage your pharmacovigilance processes within the framework of up-to-date regulation and good pharmacovigilance practices.
We ensure business continuity with a quality and effective service and pursue your pharmacovigilance liabilities uninterruptedly on behalf of you.
Pharmacovigilance
Outsource Service
Employment of personnel with a profile in line with the client company’s expectations is made by using the competency-based interview techniques.
On-the-job orientation training program service is provided for the personnel to be employed by the experienced trainers within the scope of legislation and pursuant to the client’s procedures and requests.
On-the-job orientation training program service is provided for the personnel to be employed by the experienced trainers within the scope of legislation and pursuant to the client’s procedures and requests.
Personal Data Protection
Our Products
Our Services
Demo Request
If you need any information or request a demo about our services and products, please contact us by following this link.
Contact Us
Fetih Mah. Tahralı Sk. Kavakyeli İş Merkezi No:7 A Blok Kat:10 D: 26
Ataşehir/İstanbul/Turkey
☎ +90 216 326 77 12
📠 +90 216 428 39 71
📧 contact＠pharmasoft.com.tr
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