Marketing authorization of biologically active additives
Registration of biologically active additives
Our services for registration and certification of biologically active additives (BAA) in Russia include:
Registering biologically active additives of domestic and foreign manufacturers
Providing highly skilled document translation (for foreign manufacturers)
Developing specifications and process instructions (for domestic manufacturers)
Selecting manufacturing sites (for domestic manufacturers)
Arranging for laboratory testing of the BAA before submission for state registration
Providing customs support for samples (for imported products)
Arranging for and monitoring the evaluation for state registration
Arranging for and monitoring the evaluation performed by Rospotrebnadzor
(the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, Russian Federation)
Amending the existing expert findings and certificate of state registration
We offer a comprehensive solution for the registration of biologically active additives to food
I
Preliminary dossier evaluation
- Perform an initial evaluation of the dossier and provide client consultation
- Determine whether laboratory testing is required prior to applying for marketing authorisation
- Evaluate the completeness of the materials submitted and their compliance with registering agency requirements
- Calculate the cost of registration and come to an agreement with the client
II
Preliminary laboratory testing of the BAA if applicable, as determined in Stage I
- Execute contracts and applications for the test centre
- Translate manufacturer documents (for foreign BAAs)
- Compile the dossier
- Monitor the evaluation status
- Submit additional materials and data upon request by the competent authority
- Obtain the expert findings
III
Submission of dossier and samples for evaluation
- Execution of contracts and applications for the test center
- Translation of documents of the manufacturer
- Completing of the dossier for submission
- Control over passing the expert examination
- Submission of additional materials and data upon request by the competent authority
- Obtainment of an expert report
IV
Submission of files to Rospotrebnadzor
- Compile and finalize dossier
- Execute the application
- Submit the dossier to Rospotrebnadzor
- Monitor the evaluation status
- Submit additional materials and data upon request by Rospotrebnadzor
V
Completion of the registration procedure, inclusion of the BAA in the state registry
- Obtain the marketing authorisation certificate and transfer it to the client
Get advice on marketing authorization of biologically active additives
If you have any questions, or would like to contact us for any reason, please use the form on the right. We do our best to respond as quickly as possible. Please, enter your real telephone number and we will call you back soon. Also, if you would like us to call you back with an answer to your specific queries, then please, describe give us full details in this message. We are looking forward to hearing from you!
Contact information
Line №1: +7 (495) 120-11-64
Line №2: +7 (495) 120-11-59
Line №3: +7 (903) 748-60-35 (English-speaking consultant)
Line №4: +7 (958) 561-33-87
WhatsApp: +7 (958) 561-33-87