3. Regulatory affairs / registration services
"Tonus-Les" has been performing registration of medicinal products since 2001, and in 2012 started providing services in this field.
Since 2012, we have prepared for registration about 100 dossiers for drugs of partners who have granted us exclusive distribution rights, including the preparation of missing modules on preclinical and clinical studies, writing of SmPC and insert-leaflets, development of packaging artworks, preparation of pharmacovigilance system master files, PSUR / PBRER, development and/or validation of analytical methods, etc. Moreover, 3 CTD format dossiers have been fully compiled in English and Russian within provision of contract services.
We have registered more than 600 drugs in Armenia, Georgia and Kazakhstan since 2001.
Since 2016, “Tonus-Les" also provides services in regulatory affairs and pharmacovigilance to the largest drug manufacturers in the EU within the cooperation with 2 famous European CROs.
Our experts will advise you on regulatory questions related to state registration, re-registration and amendments to the medicinal product dossier, depending on the required regulatory procedure. We provide information on the required documents and expertise rules and approaches, help to select the most appropriate regulatory procedure, provide information on the timing of implementation various regulatory procedures, etc.
Preliminary assessment of the medicinal product dossier
Our experts perform a preliminary assessment of your dossier and advise on bringing documentation into compliance with the requirements of the selected regulatory procedure. Services include:
- evaluation of the registration dossier (modules 1-5);
- identifying inconsistencies with the requirements of the regulatory procedure and proposing appropriate solutions;
- re-evaluation of the dossier after making corrections.
Formal submission of the dossier to the Authorized body and maintenance of the regulatory procedure
Our specialists act as your local representative in Armenia for registration / re-registration of your products. Services include:
- compilation of the final version of the dossier for formal submission to the Authorized Body, depending on the selected regulatory procedure;
- formal submission of the dossier, as well as samples and standards to the Authorized Body;
- receiving requests and formal submission of responses to queries;
- communication with experts on issues arisen;
- obtaining the Ministry of Health order on approval and registration certificate;
- other necessary actions within the selected regulatory procedure.
CTD dossier preparation in accordance with EU and EAEU requirements
Our experts will assist you in preparation your medicinal product dossier (in full or selected sections), in CTD format, both in accordance with the requirements of the European Union and the Eurasian Economic Union. Services include:
- preparation of the administrative part (module 1) based on the provided documentation, including the preparation of the summary of medicinal product characteristics and the insert-leaflet (in the required format); development of packaging artworks, preparation of pharmacovigilance system master files, PSUR / PBRER, etc.
- preparation of a quality overall summary (module 2.3);
- writing a non-clinical overview and summaries (module 2.4 / 2.6);
- writing a clinical overview and summaries (module 2.5 / 2.7);
- preparation of module 3 (based on documents provided by the manufacturer) and normative documentation;
- preparation of modules 4 and 5.
We work with the following regulatory procedures:
- registration of a medicinal product according to the national procedure of the Republic of Armenia
- re-registration of a medicinal product according to the national procedure of the Republic of Armenia
- amendments to the medicinal product dossier according to the national procedure of the Republic of Armenia
- registration of a medicinal product according to the EAEU procedures (mutual recognition and decentralized procedure)
- re-registration of a medicinal product according to the EAEU procedures
- amendments to the medicinal product dossier according to the EAEU procedures
Tonus-Les also provides registration services for medicinal products in Georgia and Kazakhstan.