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Questionnaire for preparing a commercial proposal for the inclusion of an API in the State Register of Medicinal Products
Your company name
INN or group name
*
Has an application for inclusion of this pharmaceutical substance in the State Register of Medicinal Products been submitted previously?
*
Yes
No
In which country is the manufacturing site (sites) located?
*
Does the manufacturer have a valid GMP certificate issued according to the national requirements of an EAEU member state or EAEU requirements?
*
Yes
No
Do you need assistance in preparing the Normative Documentation (ND)?
*
Yes
No
Do you need assistance in aprobation of analytical procedures?
*
Yes
No
Do you need assistance in submitting the electronic dossier to the regulatory authority?
*
Yes
No
Desired deadline for dossier preparation
Additional conditions and requests
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Your name
*
Email
*
Phone number
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