Prices
| Raifarm service fee (Russian Ruble)1 | |||
| Services | Terms (months)8 | min | max |
| Fixed service fees (milestones based) 2 | |||
| Drug registration in Russia as the Referent State of EAEU 3 4 | 15-1810 | 3900000 | 6900000 |
| The consequent recognition of the drug in one of the Confirmation State of EAEU | 6-10 | 350000 | 900000 |
| National RB or RK dossier alignment with EAEU requirements and the following geography extension to Russia | 10-12 | 2900000 | 3900000 |
| National RF dossier alignment with EAEU requirements | 10-12 | 1900000 | 3500000 |
| Readability test of patient information leaflet | 2-3 | 600000 | 900000 |
| CMC variation with expert evaluation requiring laboratory examination | 3-1511 | 900000 | 1500000 |
| CMC variation with expert evaluation not requiring laboratory examination | 3-1511 | 200000 | 800000 |
| Variation requiring evaluation of safety-efficacy ratio | 3-1511 | 500000 | 900000 |
| Administrative variation not requiring expert evaluation | 3-1511 | 150000 | 350000 |
| Gap analysis of the registration dossier to assess strategy of registration in EAEU | 200000 | 400000 | |
| GMP inspection by RF competent authorities 5 | |||
| Consulting and technical support in organization and conduction of a GMP inspection | 8-1012 | 1500000 | 2000000 |
| Mock audit prior to a GMP inspection | 3-4 | 1500000 | 2000000 |
| Price registration | |||
| Registration or renewal of the maximum selling price for a drug included into the Essential Drug List of RF 6 | 3-4 | 1500000 | 2000000 |
| Registration of medical devices (MD) 7 | |||
| Registration of MD via the national RF procedure | 10-18 | 1200000 | 2000000 |
| Registration of MD via the EAEU procedure | 12-18 | 1500000 | 2500000 |
| Administrative variation not requiring laboratory/clinical tests | 150000 | 250000 | |
| Variation requiring laboratory/clinical tests | 1000000 | 2000000 | |
| Gap analysis of an MD dossier to assess strategy of registration | 150000 | 250000 | |
| Hourly rate-based service (cost per working hour) | |||
| Local QPPV function for drug products | 12000 | 12000 | |
| Local authorized representative function for MDs | 10000 | 10000 | |
| Registration projects related services, if not rendered on the fixed cost basis 8 | 5000 | 12000 | |
| Ad hoc consulting for drug products | 15000 | 15000 | |
| Ad hoc consulting for MDs | 10000 | 10000 | |
| Translation of documentation (cost per page) | |||
| English to Russian | 700 | 700 | |
| Russian to English | 900 | 900 | |
| Non-English to Russian | 900 | 900 | |
| Notarization of translations | 300 | 300 | |
1 Service fees may range from minimum to maximum rates based on a given project’s details per our proposal acceptance.
2 Service fees exclude documentation translations, official filings, sample importation/testing costs.
3 The Eurasian Economic Union (EAEU) includes Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan.
4 Local clinical trial expenses are not included in service fees if studies are required for EAEU pre-registration. Raifarm can recommend a regional CRO partner to facilitate trials.
5 Service fees exclude documentation translations, Russian pharmaceutical institute charges, or travel expenses as applicable.
6 Pricing registration service fees consider the specific registration scenario and number of pertinent SKUs.
7 Service fees exclude documentation translations, filings, sample importation/tests, external lab/clinic services, quality management system inspection costs if required.
8 Service fees align with the expertise level of assigned Raifarm staff.
9 Timelines assume timely customer documentation provision and sample availability for required pharmaceutical examinations or medical device testing.
10 Local clinical trial timelines are not factored into specified periods if trials mandated.
11 Specified variation timeline varies by complexity.
12 Timelines assume manufacturing site accommodation of inspector visit dates.
With attentive consideration of every unique situation, Raifarm seeks to optimize partnerships for success in Russia and the EAEU. Our pricing transparency and operational flexibility underpin effective collaboration.
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