SPECTRUM OF SERVICES
- Registration of medical devices and medicines
- Complex questions of appeal, answers to complaints
- Consulting in the field of registration of medical devices
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Registration of medical devices of all risk classes and types, including equipment and devices for in vitro diagnostics:
- formation of the list of registration dossier for the product.
- assistance in the preparation / revision of documents.
- accompaniment of toxicological, clinical,
technical and clinical laboratory tests of a medical device.
- submission of documents for registration and record keeping.
- assistance in the registration process on any questions that have arisen at any stage of registration. -
Elimination of violations identified by Roszdravnadzor in the process of monitoring the circulation of medical devices:
- preparation of all necessary documents, full support of the case until a positive conclusion of the RZN is received. - Registration of medical devices and medicines abroad.
- Conclusion honey. products and medicines to the Russian and foreign markets for its commercialization.
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