HAVE A QUESTION ON THE REGISTRATION OF A MEDICAL PRODUCT?
WE WILL PROVIDE SOLUTION.
Losing time on registration?
Skipping tenders?
Delaying deadlines?
Loosing money?
Are you afraid to get a refusal?
Consulting services
PREPARING THE PACKAGE OF DOCUMENTS FOR STATE REGISTRATION
DEVELOPMENT OF STATUTORY STANDARDS-COMPLIANT DOCUMENTATION
TECHNICAL TESTS
Toxicological tests (tests to assess the biological effects of Medical Products)
Clinical trials (research studies)
SUBMISSION OF DOCUMENTS TO ROSZDRAVNADZOR (Federal Service for Surveillance in Healthcare)
Receipt and transfer of registration certificate to the client
CERTIFICATION OF MEDICAL PRODUCTS
TESTS FOR THE APPROVAL OF THE TYPE OF MEASUREMENT INSTRUMENTS. OBTAINING THE CERTIFICATE OF APPROVAL FOR THE TYPE OF MEASUREMENT INSTRUMENTS.
TRANSLATION AND NOTARY CERTIFICATION OF INTERNATIONAL DOCUMENTS
Service |
PACKAGE 1 |
PACKAGE 2 |
PACKAGE 3 |
| Consultation | + | + | + |
| Dedicated account manager | + | + | + |
| Preparation of the document package required for registration of a medical product | + | + | - |
| Development of draft statutory documents (technical documentation, instructions for use, specifications) in compliance with the latest legislative acts of Russian Federation, EEU | + | + | - |
| Technical tests | - | + | + |
| Toxicological tests (tests to assess the biological effects of Medical Products) | - | + | + |
| Clinical trials (research studies) | - | + | + |
| Receipt and transfer of test results | - | + | + |
| Submission of documents to Federal Service on surveillance in Healthcare (ROSZDRAVNADZOR) | - | + | - |
| Control | - | + | - |
| Receipt and transfer of registration certificate to the client | - | + | - |
| Order | Order | Order |
10+ YEARS OF EXPERIENCE OF EMPLOYEES
248 SUCCESSFUL PRODUCT REGISTRATIONS
90% ACCEPTANCE OF DOCUMENTS ON THE FIRST FILING
24/7 RESULT-ORIENTED APPROACH
REGISTRATION OF MEDICAL PRODUCTS IN COMPLIANCE WITH
EEU RULES
.02
HOW THE PROCESS WORKS
.01
SUBMIT APPLICATION
You provide documents.
INITIAL DATA
.03
ANALYSIS OF DOCUMENTS
.04
AGREEING AND SIGNING OF THE CONTRACT
We review your document package
and provide consultation on terms
and conditions of obtaining the registration certificate.
On this stage the budget for the procedure is determined.
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DELIVERY OF DOCUMENTS
Contacts
- 8 (495) 7-999-000
- Mon -Thu 9:00 - 18:00, Fr 9:00 - 17:00 (Moscow time)
- Russian Federation, 111672, Moscow, Saltykovskaya street 26, building 1