Registration services profitable and fast

Registration Service

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List of provided services

1. Drug registration (Marketing authorization in Kazakhstan)

Medical devices and medical equipment registration
(Marketing authorization in Kazakhstan)

2. Qualified help in the design of drug packs in Kazakh and Russian languages

3) Cousultations on registration field

4) Dossier preparing for registration in Kazakhstan

 

Nowadays  Drug registration is quite complicated process which requires a full completion of a dossier on the first stage and daily control of all the steps of the registration.

In order to achieve fast registration with minimum number of delays as possible our qualified specialists of analytical group do preliminary expertise of dossiers that are being registered. Based on the expertise conducted, the conclusion will be announced, this conclusion contains comments on which the dossier has to be improved.

And only after making improvements the dossier can be passed on to registration.

 With years of experience it is well known that after going through preliminary expertise period of registration significantly shortens.

After submission of the dossier for the registration specialists of the registration office monitor the process weekly and at the same time without any delay inform the client if there are any comments or queries from the experts, they also help to explain letters in the best way and consult on any questions that can arise during the process of registration.

We prepare and present the report on the 5th of every month for our clients.

We also offer the whole range of services in the Pharmaceutical field.

We ease the process of registration for our clients by following the principle of a “One Window”- which means if you want to work with us you can use a range of services without losing your valuable time on signing contracts etc.

 

 - Regulatory Submission Service in Kazakhstan

 is responsible for preparing, submitting and maintaining the regulatory affairs operations associated with electronic regulatory submissions, including *navigational publishing, preparation of eCTD sequences and submission* through various health authority portals   

 International Regulatory Specialists in Kazakhstan is responsible for:

 
·       Prepare Design Dossiers and supplements to secure/maintain marketing approvals

·       Helping to prepare Technical Files to secure/maintain marketing approvals and update Technical Files on an annual basis

·       Prepare appropriate documentation for each 5 years renewals

·       Prepare global submissions to secure/maintain marketing approvals


·       Interface directly with Regulatory Authorities

·       Communicate and coordinate regulatory activities with other departments

 

WELCOME!