Raifarm boasts a second-to-none team of regulatory professionals. In the 12 years, we have completed more than 150 new drug registrations in Russia. Many of these products were orphan or original, a testament to our ability to achieve required results, even in the most complex regulatory undertakings.
Our team brings a wealth of experience in Russian regulatory bodies and huge international pharmaceutical companies. We’ll help you evade competition, facilitate innovation, even repurpose existing medications and devices, if necessary. Raifarm administers on-going staff trainings and gives our employees wide exposure to a variety of registration assignments, ensuring that our team is constantly perfecting their skills.
Our consultants specialize in de-risking development programs, presenting data and study reports in the form of well-reasoned arguments. This means we accurately address regulatory requirements of the given market, while also meeting the strategic needs of your company and your target markets.
The expertise of our consultants and technologies allow us to successfully identify new opportunities for our clients, anticipate complications, and efficiently manage regulatory information – protecting if from theft or counterfeiting.
We’re here to protect your products, your interests, and your growth – to meet your marketing milestones and maintain compliance.
Product regulation can be one of the most difficult areas to navigate within pharmaceutical development and marketing, and it lies at the very core of our services.
Before going to market, new drugs and medical devices must undergo an elaborate and stringent process of registration and approval. As the system is highly complex, great diligence and a specialized approach with proper skills are required to work within the pharma regulatory framework.
After clinical approval, sponsors must also apply for approval to market their new drug. New drug approvals are particularly challenging because regulatory framework and individual authorities differ from country to country, and locale to locale.
We guide our clients through every step of the drug submission process. We develop a strategy that ensures a timely and proper delivery of your regulatory application and keeps an eye on it – to maintain the lifecycle of the submission. We follow up with any necessary support to keep your product on track for success, beyond mere approval.
Raifarm’s regulatory services include
- Consultation and guidance of pharmaceutical product registration (including all up-to-date procedures): conducting local clinical trials, introduction of changes into application dossier and/or documents, and development of a strategy for dossier preparation and its submission to the Ministry of Healthcare of the Russian Federation and regulatory bodies in EuAsEC countries.
- Preparation of application dossier – including administrative documents – in compliance with current legislation, for subsequent submission to the Russian Ministry of Healthcare.
- Collaboration with client to prepare regulatory documentation for pharma products based on the manufacturer’s original operational procedures and quality control methods.
- Preparation of models of the product’s package fragments.
- Collaboration with client to prepare drug administration instructions.
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Arrangement and management of drug and agent sample importation to administer quality control (including standard sample/material samples).
- Collaboration with client to prepare responses to any inquiries from the Russian Ministry of Healthcare or the Federal State Budgetary Institution.
- Document translation and revision, as well as notary certification (if required).
- Our commitment to quality, profound knowledge of local regulations, and dedication to professionalism enable us to complete drug registration in record time. We effectively organize the entire process, including all local pre-clinical and clinical studies required for drug registration.
Price drug registration
| Service | Term (months)5 | Raifarm service fee (Euro.) 1 | |
|---|---|---|---|
| Min. | Max. | ||
| Fixed service fees (milestones based) 2 | |||
| Drug registration in Russia as the Referent State of EAEU 3 4 | 15–18 6 | 50,000 | 80,000 |
| The consequent recognition of the drug in one of the Confirmation State of EAEU | 6–10 | 5,000 | 12,000 |
| National RB or RK dossier alignment with EAEU requirements and the following geography extension to Russia | 10–12 | 35,000 | 45,000 |
| National RF dossier alignment with EAEU requirements | 10–12 | 25,000 | 40,000 |
| Readability test of patient information leaflet | 2–3 | 7,000 | 12,000 |
| CMC variation with expert evaluation requiring laboratory examination | 3–15 7 | 12,000 | 20,000 |
| CMC variation with expert evaluation not requiring laboratory examination | 3–15 7 | 3,000 | 10,000 |
| Variation requiring evaluation of safety-efficacy ratio | 3–15 7 | 7,000 | 12,000 |
| Administrative variation not requiring expert evaluation | 3–15 7 | 2,000 | 4,000 |
| Gap analysis of the registration dossier to assess strategy of registration in EAEU | 3,000 | 5,000 | |
1 Service fee may vary from min to max and will be agreed upon acceptance of Raifarm offer for a concrete case.
2 Service fee does not include documentation translations, official filing fees, expenses related to importation pf samples for laboratory examination.
3 EAEU – Eurasian Economic Union, which includes five countries: Russian Federation (RF), Republic of Belarus (RB), Republic of Kazakhstan (RK), Armenia and Kyrgyzstan.
4 If a product needs a pre-registration clinical study in EAEU Raifarm will recommend a local CRO. The indicated Service fee does not include clinical study costs.
5 The specified period assumes the timely provision by the customer of documentation, as well as, if applicable, samples for pharmaceutical examination (drugs) or testing (medical devices).
6 The specified period does not include the conduction of a local clinical trial (if required).
7 The specified period depends on the complexity of the variation.