Full cycle of registration and re-registration of medical and other products


Type of service
Cost of services
* Consultation on registration related to state duties and other paid questions
* Primary consultation - $ 100, secondary and further - $ 50.
Registration of medicines
$1500 for one drug with one dosage (for each additional dosage - $200).
Registration of the medical device / medical equipment
$1300 for one medical device / medical equipment (for each additional volume, variety - $300).
Re-registration of medicines
$1300 for one drug with one dosage (for each additional dosage - $300).
Re-registration of the medical device / medical equipment
$1100 for one medical device / medical equipment (for each additional volume, variety - $300).
Registration of dietary supplements (BAA)
$1300 for one product
Registration of perfumery and cosmetic products
$1000 for one product
Making changes to the dossier (ND, instructions, color models, etc.)
Depending on the amount of work $500-700
Conducting clinical / preclinical trials (if necessary)
$3000
Translation and / or making of instructions for use (professional translation into the state language).
Translation - $10 per page / making and translation - $15 per page.

Note:
* After signing a contract with us, all types of consulting are free.


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Pharmacopoeia Committee

Tasks of the Pharmacopoeia Committee:

- examination of normative documents for medicines subject to registration and extension of the term of registration;
- systematic revision of normative documents for medicines with a view to improving their quality and improving the methods of control;
- examination and preparation for approval of...


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Department of Registration

Tasks of the Registration Department:

- after the adoption of the application for registration, conducts the initial (preliminary) examination of the application and attached registration documents and samples of medicines, medical devices and medical equipment;
- conducts appropriate correspondence with...;

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Pharmacological Committee

Tasks of the Pharmacological Committee:

- conducts examination of administrative, pharmacological, toxicological and clinical parts of registration documents of pharmacological and (or) medicinal products;
- conducts examines and re-examines documents of pharmacological and (or) medicinal products with the involvement of...;


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