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REGISTRATION OF PHARMACEUTICALS, DIETARY SUPPLEMENTS, AND MEDICAL DEVICES
PharmAssistance provides a full range of services for the registration of pharmaceuticals, medical devices, and dietary supplements throughout the Eurasian Economic Union.
TYPES OF PRODUCTS WE REGISTER
Original pharmaceuticals
Fixed dose combinations
Generics and others
SERVICES INCLUDE
Consultation on registration strategy
Preparation and compilation of the registration dossier in CTD format
Development and analysis of technical documentation
Collaboration with testing centers and laboratories
Support during testing
Assistance with the inspection of manufacturing sites
Interaction with regulatory authorities
Conducting PIL user readability test
SERVICES INCLUDE
REGISTRATION STAGES
We guarantee comprehensive and highly qualified support, adherence to deadlines, and process control.
The final cost and timelines of the procedure will be calculated based on your request
Registration of medicines, dietary supplements and medical devices - what is it?
Registration of medicines, dietary supplements and medical devices is a mandatory procedure carried out prior to their manufacture, sale, use, import, export, storage and disposal. Its purpose is to verify the conformity of medicines (products) with the declared characteristics and parameters.
In order to obtain a certificate of state registration of a medicine, dietary supplement or medical device, they additionally undergo preclinical and clinical trials, as well as pharmaceutical expertise to identify potential risks. All these measures are taken to minimize the possibility of negative side effects and other undesirable consequences when using a new drug. Approved medicines are guaranteed to be effective and safe.
State registration of medicines, medical devices, dietary supplements throughout the EAEU and CIS countries
“PharmAssistance” LLC provides a full range of services in the field of registration of medical products. We act in accordance with the legislation and follow the established procedure for registration of medicines, food supplements and medical devices. We offer our clients:
- Free initial consultation on current issues
- GAP analysis of the registration dossier, after which we provide a checklist of the documents required for registration and comments on the registration strategy.
- Compilation of the registration dossier for submission to the relevant authorities
- Development of missing regulatory documents, package leaflets, SMPC, writing modules
- Interaction with the regulatory authorities
- Preparation of documentation package (we help to collect documents for registration of medicinal products)
- Organization of interaction with testing centers and clinical laboratories
- Information support
- Assistance in obtaining a certificate of registration
With our help, the medicine approval process will take minimal time, and you will be able to bring the medicine to market on time and achieve the financial results you need.
Registration of Control Results for Medicines, Medical Devices and Dietary Supplements: Why Choose Us?
- Our team consists of qualified personnel with extensive experience in medicine registration in the EAEU and CIS countries.
- We strictly comply with the legal requirements for registration and review of medicinal products.
- We help to solve the most complex cases
- We work out individual strategies for each project
- We closely cooperate with professional research laboratories and centers
- We guarantee full confidentiality of your information
- Registration of medicinal products in Russia, CIS and EAEU is fast and easy with us.
Medicine development and registration with the help of PharmAssistance
Please use the contact information to start our cooperation. With our help, you can successfully register your products and make them available to consumers in many countries.
