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Registration of drugs and medical devices
Our company has provided registration services since 2007. We have practical experience with drug registration in EU countries, Serbia, Belarus, Kazakhstan, and Uzbekistan
We focus on:
- registration of drugs and medical devices
- notification of dietary supplements and cosmetic preparations
We can prepare the process of:
- national registration
- MRP procedure
- DCP procedure
- central registration including EMA consultation
Our strength is knowledge of the process of research, development, clinical studies and manufacturing – processes associated with manufacturing (see industry experience). This expertise allows us to evaluate the registration documentation for individual registration processes. To propose amendments, revisions, and subsequently to cover such proposals in writing (amendments) Modules I, II, III, IV and V .
Services associated with the process at the authority:
- Preparation, sequencing of documentation, and submission of the application
- Assistance in answering questions during the process
- Consultations at the authority
- We provide these services as a package or individually.
- In accordance with the latest European recommendations and, if interested, also FDA recommendations.