Get medicinal product registered on a turnkey basis
Hurry up to bring the registration dossier of medicinal product into compliance with the EAEU Rules with us before December 31, 2025
How do we do that?
Preparing a dossier for submission
We put together and form an xml dossier
Dossier audit
We conduct the most comprehensive analysis and give specific recommendations
Strategy development
We determine the timeline and provide registration options
Obtaining a marketing authorisation
And approved documents
Submission of the dossier and monitoring
We follow-through on all expertise stages and help to respond to requests from the Regulatory authorities
Advantages of registration on a turnkey basis
Receiving comprehensive services through single contract
Exclusion of critical moments before submitting the registration dossier to the regulatory authorities
A well-designed dossier
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Advantages
Send the request
Please contact us if:
We can help you out if you are having difficulties in regulatory issues. Just leave your request and get a free consultation
you are worried about your products
you have no idea what to do
you are tired of the trivial offerings
you are ready to go to the end
you are not afraid of criticism about your product
you lack or don't have enough experience of registration according to the EAEU Rules
We can help you out if you are having difficulties in regulatory issues. Just leave your request and get a free consultation
Why you should contact us?
Expertness
We are not regulatory affairs managers or specialists. We are EXPERTS
We are starting point in your product's life cycle on the EAEU territory
In-house software development
JYLDAM portal solution developed in cooperation with itave to convert dossiers into xml format
Uniqueness
We have experience working in various departments of the Expert Organization
Time
Speed helps to save time and accelerate speed to market
Experience
We have more than 10 years of experience in the registration
Speed
Expertise helps to handle requests and solve problems quickly
entrypoint serves as a starting point for the pharmaceutical registration process
We provide comprehensive service using the expert organization's operating model, which includes analysis, preparation of all necessary documents and consultations on the registration, ensuring confidence in the present and the future
Our mission is to provide a professional service for registration of medicinal products in order to improve public health and guarantee the accessibility of high-quality medicines
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What can we do?
Pharmaceutical registration procedures
Registration on a turnkey basis:
Procedure for bringing the registration dossier into compliance with the requirements of the EAEU
Registration of a medicinal product according to the mutual recognition procedure (as a reference state or concerned member state)
Registration of a medicinal product according to the decentralized procedure (as a reference state or concerned member state)
Confirmation of registration (re-registration) of a medicinal product
Amendments to the registration dossier of a registered medicinal product
Registration of a medicinal product according to the mutual recognition procedure (as a reference state or concerned member state)
Registration of a medicinal product according to the decentralized procedure (as a reference state or concerned member state)
Confirmation of registration (re-registration) of a medicinal product
Amendments to the registration dossier of a registered medicinal product
Pharmaceutical registration procedures
Registration on a turnkey basis:
Procedure for bringing the registration dossier into compliance with the requirements of the EAEU
Registration of a medicinal product according to the mutual recognition procedure (as a reference state or concerned member state)
Registration of a medicinal product according to the decentralized procedure (as a reference state or concerned member state)
Confirmation of registration (re-registration) of a medicinal product
Amendments to the registration dossier of a registered medicinal product
Registration of a medicinal product according to the mutual recognition procedure (as a reference state or concerned member state)
Registration of a medicinal product according to the decentralized procedure (as a reference state or concerned member state)
Confirmation of registration (re-registration) of a medicinal product
Amendments to the registration dossier of a registered medicinal product
Development of registration dossier documentation
Summary of Product Characteristics
Patient information leaflet (package insert)
Normative document
2.3. Quality Overall Summary
2.4. Nonclinical Overview
2.5. Clinical Overview
2.6. Nonclinical Summary
2.7. Clinical Overview
Patient information leaflet (package insert)
Normative document
2.3. Quality Overall Summary
2.4. Nonclinical Overview
2.5. Clinical Overview
2.6. Nonclinical Summary
2.7. Clinical Overview
Development of registration dossier documentation
Development of registration dossier documentation
Summary of Product Characteristics
Patient information leaflet (package insert)
Normative document
2.3. Quality Overall Summary
2.4. Nonclinical Overview
2.5. Clinical Overview
2.6. Nonclinical Summary
2.7. Clinical Overview
Patient information leaflet (package insert)
Normative document
2.3. Quality Overall Summary
2.4. Nonclinical Overview
2.5. Clinical Overview
2.6. Nonclinical Summary
2.7. Clinical Overview
Development of registration dossier documentation
User package insert testing
preliminary assessment of the package insert
translation of the SmPC and PIL into Kazakh language (if any)
preparation of the test protocol
conducting a pilot phase
analysis of the pilot phase results
conducting a core phase
analysis of the core phase results
preparation of the final report
translation of the SmPC and PIL into Kazakh language (if any)
preparation of the test protocol
conducting a pilot phase
analysis of the pilot phase results
conducting a core phase
analysis of the core phase results
preparation of the final report
User package insert testing in Russian and Kazakh languages
User package insert testing
preliminary assessment of the package insert
translation of the SmPC and PIL into Kazakh language (if any)
preparation of the test protocol
conducting a pilot phase
analysis of the pilot phase results
conducting a core phase
analysis of the core phase results
preparation of the final report
translation of the SmPC and PIL into Kazakh language (if any)
preparation of the test protocol
conducting a pilot phase
analysis of the pilot phase results
conducting a core phase
analysis of the core phase results
preparation of the final report
User package insert testing in Russian and Kazakh languages
Pharmacovigilance
Development and implementation of a pharmacovigilance system
QPPV services on the EAEU territory
Pharmacovigilance contact person services
Development of a risk management plan (RMP)
Development of a Periodic Safety Update Report (PSUR)
QPPV services on the EAEU territory
Pharmacovigilance contact person services
Development of a risk management plan (RMP)
Development of a Periodic Safety Update Report (PSUR)
Pharmacovigilance
Pharmacovigilance
Development and implementation of a pharmacovigilance system
QPPV services on the EAEU territory
Pharmacovigilance contact person services
Development of a risk management plan (RMP)
Development of a Periodic Safety Update Report (PSUR)
QPPV services on the EAEU territory
Pharmacovigilance contact person services
Development of a risk management plan (RMP)
Development of a Periodic Safety Update Report (PSUR)
Pharmacovigilance
Medical device registration procedures
The service includes:
documents collection and analysis;
preparation of an application, specification, table versions;
formation of a dossier for submission;
analysis of comments from the Regulatory authorities, consultation and assistance in their removal;
registration stages monitoring and periodic notification of the current work/progress report status, obtaining a marketing authorisation
Advice schemes relating to inspections
collection of the necessary documents for the dossier
conclusion of an agreement with the Regulatory authorities for an inspection, submitting an application and receiving an invoice for the inspection;
agreement of dates with the manufacturer and inspectors;
communication on the audit plan, transfer and other matters with inspectors
preparation of an application, specification, table versions;
formation of a dossier for submission;
analysis of comments from the Regulatory authorities, consultation and assistance in their removal;
registration stages monitoring and periodic notification of the current work/progress report status, obtaining a marketing authorisation
Advice schemes relating to inspections
collection of the necessary documents for the dossier
conclusion of an agreement with the Regulatory authorities for an inspection, submitting an application and receiving an invoice for the inspection;
agreement of dates with the manufacturer and inspectors;
communication on the audit plan, transfer and other matters with inspectors
Registration on a turnkey basis:
Registration
Re-registration
Variation
Re-registration
Variation
Medical device registration procedures
Registration on a turnkey basis:
documents collection and analysis;
preparation of an application, specification, table versions;
formation of a dossier for submission;
analysis of comments from the Regulatory authorities, consultation and assistance in their removal;
registration stages monitoring and periodic notification of the current work/progress report status, obtaining a marketing authorisation
Advice schemes relating to inspections
collection of the necessary documents for the dossier,
conclusion of an agreement with the Regulatory authorities for an inspection,
submitting an application and receiving an invoice for the inspection;
submission of approval letters for the inspection;
agreement of dates with the manufacturer and inspectors;
communication on the audit plan, transfer and other matters with inspectors;
preparation of an application, specification, table versions;
formation of a dossier for submission;
analysis of comments from the Regulatory authorities, consultation and assistance in their removal;
registration stages monitoring and periodic notification of the current work/progress report status, obtaining a marketing authorisation
Advice schemes relating to inspections
collection of the necessary documents for the dossier,
conclusion of an agreement with the Regulatory authorities for an inspection,
submitting an application and receiving an invoice for the inspection;
submission of approval letters for the inspection;
agreement of dates with the manufacturer and inspectors;
communication on the audit plan, transfer and other matters with inspectors;
The service includes:
Registration
Re-registration
Variation
Re-registration
Variation
BADs registration
BAD composition verification before registration;
obtaining the test protocol, scientific and expert report from the Institute of Nutrition;
applying for a State Registration Certificate (SRC)
with all dossier and testing documents;
obtaining the SRC
obtaining the test protocol, scientific and expert report from the Institute of Nutrition;
applying for a State Registration Certificate (SRC)
with all dossier and testing documents;
obtaining the SRC
Registration on a turnkey basis includes:
BADs registration
BAD composition verification before registration;
obtaining the test protocol, scientific and expert report from the Institute of Nutrition;
applying for a State Registration
Certificate (SRC);
dossier and testing documents;
obtaining the SRC
obtaining the test protocol, scientific and expert report from the Institute of Nutrition;
applying for a State Registration
Certificate (SRC);
dossier and testing documents;
obtaining the SRC
Registration on a turnkey basis includes:
Training
The entrypoint academy subdivision accepts applications for training of young regulatory affairs manager and specialists within the EAEU
Training
Training
The entrypoint academy subdivision accepts applications for training of young regulatory affairs manager and specialists within the EAEU
Training
Translation services
Translation services
From Russian to Kazakh
From Kazakh to Russian
From English to Russian
From English to Russian
From English to Kazakh
And other languages
From Kazakh to Russian
From English to Russian
From English to Russian
From English to Kazakh
And other languages
Translation services
Translation services
From Russian to Kazakh
From Kazakh to Russian
From English to Russian
From English to Russian
From English to Kazakh
And other languages
From Kazakh to Russian
From English to Russian
From English to Russian
From English to Kazakh
And other languages
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