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REGISTER YOUR MEDICINES WITH US AND DISCOVER POTENTIAL OF THE EURASIAN ECONOMIC UNION MARKET
YOUR LIFE SCIENCES CONSULTING PARTNER FOR EURASIAN ECONOMIC UNION (EAEU): RUSSIA, BELORUSSIA, KAZAKHSTAN, ARMENIA, KYRGYZSTAN
REGULATORY CONSULTING FOR MEDICINAL PRODUCTS: DRUGS, MEDICAL DEVICES, DIETARY SUPPLEMENTS
MARKETING AUTHORIZATION OF MEDICINAL PRODUCTS
Our multi-disciplinary team
can help you with
- Product marketing authorization and lifecycle management
- Regulatory intelligence and strategy building
- Optimal regulatory strategy for various types of drugs: innovator medicines, generics, hybrids, well-established use medicines
- Scientific and regulatory justifications for aligning with your strategic goals
- Medical writing: Modules 1-5 CTD, pre-clinical and clinical study documents, pharmacovigilance documents
- Building complete registration dossier and submission to the Health Authorities
- Interaction with global and local Health Authorities
- Full support of the registration process: responses to requests of Regulatory Authorities, accurate control at all stages
- GxP audit preparation and inspection readiness
- Pre-clinical and clinical studies
- Preparation of SmPC and patient information leaflet
- Patient leaflet readability testing
- Labeling review and compliance with local and reference labels
- Regulatory Landscape Assessment
- Analysis of the EAEU market potential with assessment of sales volume
How we do this:
- Receive information about your product
- Perform comprehensive assessment and classification
- Perform regulatory gap analysis
- Develop optimal and effective regulatory strategy and submission plan depending on medicine type
- Craft accurate compliant regulatory documents to avoid critical inquiries from Health Authorities or refusal
- First-time quality preparation, publishing and submission of regulatory dossier
- Continuous checking at what stage the procedure is, accompanying with our tailored support
- Control Regulatory Authorities feedback and provide timely responses
- Your product is registered in the EAEU
EAEU - THE MOST PROMISING AND LARGEST MARKET AMONG POST-SOVIET STATES
1
Russia, Belorussia, Kazakhstan, Armenia, Kyrgyzstan
2
About 14 % of world’s land area
3
Inventory shortage of ≥ 100 essential medicines, unmet medical needs
4
Total population more than 184 million people
We offer optimal registration strategy allowing you enter to the EAEU market Cheaper and Easier and Faster by means of:
Cheaper
Preparation of scientific and regulatory justifications for potential waiver of [additional] studies
Minimal expenses for conducting pre-clinical and clinical studies
Easier
Assessment of possibilities of recognizing results of researches conducted outside the EAEU
Evaluation of opportunities for simplified authorization of medicinal products, abridged applications
Marketing authorizations in the 5 countries with a single GMP-certificate
Faster
Authorization of medicines on an exceptional basis for orphan drugs, gene therapy drugs, etc.
Authorization on a basis of simplified registration dossier for homeopathic and herbal medications, some vaccines, etc.
- Multi-disciplinary team with 17+ year experience in the pharmaceutical industry in the local and global international pharmaceutical companies and CROs
- Past working experience for governmental Regulatory Authorities
- Maintaining effective scientific interaction with the Health Authorities of EAEU
- 150+ medicines received marketing authorizations in the Eurasian Economic Union over the last 6 years
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Our knowledge and experience, administrative resources and business networks in the field of medicines’ development and registration allow us to avoid potential issues or stop-factors prior to and during filing of registration dossier to Regulatory Authorities
Our clients
Contacts
Office
8, Vorotnikovskiy side-street, building 1, 127006 Moscow, Russia
consult@reg-strategy.org
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