Pharmacovigilance Solution Partner

ABOUT US

DeltaPV İlaç Danışmanlık Sağlık Ürün. Ve Hiz. A.Ş. was established in 2011. DeltaPV is an expert on pharmacovigilance area. In May 2012 inspected by Ministry of Health and in December approved as the first acredited Pharmacovigilance Service Provider. At the end of 2014, DeltaPV was inspected by MoH and renewed the certificate.

Provide pharmacovigilance services at the highest quality with our expert team of pharmacists who have experience in the field of pharmacovigilance.

Being the first choice for our business partners since 2011, carrying our valuable knowledge to the international area.

In the direction of our partners demands, we closely follow the technological developments related to the sector in which we operate; to increase customer satisfaction and to be an indispensable supplier of our customers by providing services in accordance with the law and legislative requirements at the most appropriate cost, best quality and desired times.

Our quality management system aims to continuously improve our development by making all the necessary improvements in our services, in our processes and in our system in a timely and effective manner.

Our most valuable source is our employees. To organize and maintain the educational activities in order to bring each one to the best possible position to work, to have a sense of knowing the goal and reaching it, and to increase the productivity.

To comply with the requirements of the quality management system by ensuring continuity and improvement of the quality management system.

PHARMACOVIGILANCE

According to the " Regulation On The Safety Of Medicines" published in the Official Gazette on April 15, 2014, the pharmacovigilance obligations of the pharmaceutical companies which have a license or are on the license application have increased. DeltaPV undertakes all pharmacovigilance operations of the pharmaceutical companies in accordance with the Guidance on Good Pharmacovigilance Practices.

PHARMACOVIGILANCE SERVICES


•  Pharmacovigilance system setup
•  Adverse reactions management
•  Adverse reactions medical review and MedDRA encoding
•  Literature screening and interpretation
•  In-house pharmacovigilance trainings
•  Risk management plan preparation and submission
•  Crisis management
•  Medical devices vigilance activities
•  Cosmetovigilance undesired effects notifications
•  VigiDataPV database usage
   •  VigiDataPV is a web based, validated database that enables the recording and archiving of cases reported or archived in accordance with local regulations, developed by DeltaPV.
•  Support in the preparation process of the Dear Doctor Letter
•  Pre-Audit / In-Audit Support
•  Monitoring and submitting of the safety warnings
•  Periodic Benefit-Risk Evaluation Report (PBRER) preparation and submission
•  Pharmacovigilance System Master File preparation
•  Archiving all documents related pharmacovigilance activities

LITERATURE SCREENING SERVICES


Literature screening service is conducted via LITSIS which is developed by DeltaPV. over 300 national and international journals are being screened with LITSIS. It is a web-based application that enables to archive weekly literature screeninig chronologically and on a company basis.

ADDITIONAL SERVICES


In line with the request of the marketing /authorization holders , the following services are carried out on a project basis.
•  In-house pharmacovigilance trainings
•  Risk management plan preparation
•  Support in the preparation process of the Dear Doctor Letter
•  Pre-Audit / In-Audit Support
•  Periodic Benefit-Risk Evaluation Report (PBRER) preparation and submission
•  Pharmacovigilance System Master File preparation

OUR REFERENCES


A LEADER IN ITS FIELD
Providing service in pharmacovigilance
reaching 150 companies since 2011...






CERTIFICATES

DeltaPV is the First Contracted Pharmacovigilance Service Provider Company in Turkey. DeltaPV aims to provide solutions to problems faced in the field of pharmacovigilance with lower costs and to ease the burden of companies with the capacity to catch details following safety with its technical expertise and expert team.

    


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CONTACT

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Address: İçerenköy Mahallesi
Üsküdar-İçerenköy Yolu Caddesi
Bodur İş Merkezi No:8 Kat:3 D:12-19-29
Ataşehir / İstanbul
Tel : 0216 385 93 33
Fax: 0216 385 97 07
Email: info@deltapv.com
Email: pv@deltapv.com


Please fill out the TÜFAM NOTIFICATION FORM for reporting side effects/adverse reactions and send to pv@deltapv.com