Medicinal regulations are rigid and complex, and it is often a challenge to fulfill them all on time.
Medicinal regulations are rigid and complex, and it is often a challenge to fulfill them all on time.
Medicinal regulations are rigid and complex, and it is often a challenge to fulfill them all on time.
Our team provides you with a multidisciplinary approach to gathering information on current regulations and considering potential solutions for market access in the Republic of Serbia, Montenegro and in other countries in the region.
Professional approach, fast and detailed preparation of the dossier enable a shorter registration procedure, and thus faster obtaining an MA and placing your medicine on the market. Allow us to help you with that.
We also provide a high-quality document translation service as part of the preparation of complete documentation for the registration of medicines or individual documents (SmPC, PIL, LL). We can also help you with the translation of promotional and educational material, provide second quality control of the production and accuracy of the final documents with a medical review.
Preparation of tests of understanding the Patient information leaflet, as part of the documentation for registration or renewal of the medicine, as well as when changing the medicines dispensing regimen and switching from Rx to OTC status.
Registration Process Follow-Up
Prepare the documentation necessary to submit applications for variations and renewals of the MA during the entire life cycle of your medicine.
Preparation and submission of complete documentation for obtaining the maximum price of the medicine through the proper preparation of the price proposal and the development of pharmacoeconomic indicators.
Preparation and submission of complete documentation for placing the drug on the Reimbursement List, with the preparation of pharmacoeconomic analysis and pharmacotherapeutic opinion.
Collection and monitoring of adverse drug reactions, literature review, preparation of local PV documents for reporting to ALIMS and CInMED.
Tiršova 5a, Savski Venac,
11 000 Belgrade, Serbia
Montenegro:
Dositejeva 75
85310 Budva, Crna Gora
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