Professional linguistic support for the medical and pharmaceutical business
The service is provided by native speakers or professional translators. A glossary and termbase is created for each client, which ensures the use of consistent terminology. When translating, proofreading and formatting are performed by default, which ensures the translation quality
Medical translation is characterized by such features as specialized medical terminology and medical acronyms and abbreviations
Complex document format
Difficulties arising from ignorance of acronyms and abbreviations
Misunderstanding of the original text and painstaking work with dictionaries and reference books
The procedure may take a long time
You save time, and therefore money
We have a team of translators specializing in different areas of regulatory activity
Safekeeping of documents up to 7 years
We guarantee confidentiality
We guarantee full and highly qualified support,
keeping deadlines and high-quality translation
List of services:
Written translation
Interpretation
Text editing and proofreading
Notarization
Renting equipment for simultaneous translation
Remote simultaneous translation platform
Translation stages:
Document evaluation
Calculation
Approval
of cost and deadlines
Translation
Editing
Proofreading
Formatting
Checking by a personal manager
assigned to each company
Receiving
the finished document
Service cost
State license fee
5 MCI (monthly calculation index)
The final cost and deadlines of translation are calculated at your request
Questions and Answers
1. How is the document calculated?
Documents are calculated in characters. One page equals 1800 characters with spaces.
1. Why do medical devices undergo testing?
To confirm
that the product meets the declared technical characteristics, does not pose a
danger to human health, and has clinical effectiveness
1. Is it possible to suspend or revoke the registration certificate of a medicine?
Yes, registration is canceled if the registration certificate expires or if this medicine has not been in circulation for more than 3 consecutive years. In addition, its effects may be revoked in the following cases:
• new risks or side effects were found during use;
• information specified in the certificate changed (information about the manufacturer, dosing, and form);
• the manufacturer submitted a request to cancel the registration
1. Kazakhstan Drug Registration Process
2. Kazakhstan List of documents for VIRU-LS
2. What is the period of registration of a medicine?
By law, the registration period is determined as follows:
If you have a complete package of documents, 210 calendar days, not including
the preclinical period, the period of clinical trials, the time to eliminate
remarks, and inspection of the manufacturing site
3. When is it not possible to conduct clinical or preclinical trials?
When
the drug is registered and in circulation for more than 20 years. In all other
cases, clinical trials are a mandatory part of the procedure.
1. List of documents required for registration
List of documents required for the provision of public services on application of an Applicant (or his/her representative by power of attorney) according to the technical regulations of the Customs Union: List of documents-dietary supplement
1. Which documents are required to obtain an import license for medical equipment in Kazakhstan?
According to TR CU 009/2011 requirements, for state registration, it is necessary to submit the following:
• an application
• samples of labels and packages
• certified copies of technical documentation (enterprise standard and instruction)
• documents confirming the quality of the product and compliance with the claimed characteristics
• acts and reports of accredited laboratories and research centers
• copies of documents about all essential attributes of a product (organoleptic, physical, microbiological, chemical, etc.)
• annotations with all information about the properties of the specified preparation, instruction for use, and precaution
• manufacturer’s founding documents
1. Which documents on the status of pharmacovigilance activities are required to be submitted?
1) List of the principal data on the medicine of the product license holder
2) Master-file of the pharmacovigilance system (after signing a contract)
2. Are illustrations, images and graphics included in the calculation of a document?
Graphic illustrations are not included in the calculation if there is no text on them that needs translation.
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Согласие на обработку персональных данных
Настоящим в соответствии с Федеральным законом № 152-ФЗ «О персональных данных» от 27.07.2006 года свободно, своей волей и в своем интересе выражаю свое безусловное согласие на обработку моих персональных данных , зарегистрированным в соответствии с законодательством РФ по адресу: (далее по тексту - Оператор). 1. Согласие дается на обработку одной, нескольких или всех категорий персональных данных, не являющихся специальными или биометрическими, предоставляемых мною, которые могут включать:
- Имя; - Телефон; - E-mail; - Комментарий.
2. Оператор может совершать следующие действия: сбор; запись; систематизация; накопление; хранение; уточнение (обновление, изменение); извлечение; использование; блокирование; удаление; уничтожение.
3. Способы обработки: как с использованием средств автоматизации, так и без их использования.
4. Цель обработки: предоставление мне услуг/работ, включая, направление в мой адрес уведомлений, касающихся предоставляемых услуг/работ, подготовка и направление ответов на мои запросы, направление в мой адрес информации о мероприятиях/товарах/услугах/работах Оператора.
5. В связи с тем, что Оператор может осуществлять обработку моих персональных данных посредством программы для ЭВМ «1С-Битрикс24», я даю свое согласие Оператору на осуществление соответствующего поручения ООО «1С-Битрикс», (ОГРН 5077746476209), зарегистрированному по адресу: 109544, г. Москва, б-р Энтузиастов, д. 2, эт.13, пом. 8-19.
6. Настоящее согласие действует до момента его отзыва путем направления соответствующего уведомления на электронный адрес mamedov.emin@gmail.com или направления по адресу .
7. В случае отзыва мною согласия на обработку персональных данных Оператор вправе продолжить обработку персональных данных без моего согласия при наличии оснований, предусмотренных Федеральным законом №152-ФЗ «О персональных данных» от 27.07.2006 г.