About company
Tetis International is a national pharmaceutical distribution company. Our primary focus is to cover the needs of medical and pharmacy institutions in quality pharmaceuticals all over the country.
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Registration services / Pharmacovigilance

       TETIS diligently helps its partners with medicine registration process, registration of food supplements as well as medical devices in the Republic of Moldova. Our professionals will render assistance if you need to register a medicine, a medical product, or a parapharmaceutical product, including personal hygiene products. We will help you to prepare the necessary set of documentation, so that certification takes place as soon as possible. A lot of medicine manufacturers from Western and Eastern Europe took advantage of TETIS professionals. Among them are Alcon, Novartis, Pfizer, etc. 


Contact our Certification Manager Malvina Marfin:

 

e-mail: malvina.marfin@tetis.md

 

tel. :    +373 22 44 50 65.

 


         Pharmacovigilance is a system for monitoring, analyzing and evaluating information on the safety of registered medicines. The qualified staff of the TETIS company has been trained and has sufficient experience in pharmacovigilance management.

The range of pharmacovigilance services includes:

·     Literature monitoring sources approved in Moldova;

·     Local web and social networks pages monitoring;

·     Communication betweem MAH and Medicines and Medical Devices Agency if necessary;

·     Communication with doctors, patients to gain any information if it necessary for PV issues;

·     PV manager availability within 24 hours;

·     Ensurance of subcontractor with PV regulations, law, orders addopted în the RM  on language stipulated in the contract for pharmacovigilance services;

·     Detection, processing, validation and transmittion of  signals from subcontractors to Regulatory Affairs and vice versa;

·     Trainings on pharmacovigilance to  keep the high-level competentce of company personnel involced in functionality of the pharmacovigilance system;

·     Prevention of subcontractor about the information that must be submitted to the Agency Medicines and Medical Devices Agency.

·     Transmission of SUSARs, PSUR, DSUR, RMP from subcontractor to Agency for Medicines and Medical Devices.


Contact our PV manager Nadejda Neronova:

 

e-mail: nadejda.neronova@tetis.md

 

tel .:    +373 22 406 408

 

mob.:  +373 611 49 414.   

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