Our expertise
01
API
Active Pharmaceutical
Ingredient Registration
Detailed information
Timelines:
up to 6-8 months
State Fees:
around 2500 $
Result:
Registration of new API and Inclusion
into the State Governmental register
of API`s
02
GMP
Russian GMP
Certificate
Detailed information
Timelines:
up to 10-12 months
State Fees:
around 47 200 $ (7 500 + 2 800 000 Rub)
Result:
Receipt of the Russian
GMP certificate
03
Branded Formulations
(Finished product) Registration
Detailed information
Timelines:
up to 18-24 months
State Fees:
CT/BE permission around —
2000$ (110 000 + 5 000 Rub)

Document expertise & Quality Control \
(Pharmexpertise) —
5600$ (325 000 + 10 000 Rub)
Result:
Receipt of the Registration
Certificate (RC)
04
HP – Herbal Products
Biologically Active Food
Supplements Registration
Detailed information
Timelines:
up to 4-6 months
State Fees:
around 600 $
Result:
Receipt of the Registration
Certificate
05
Cosmetics
Cosmetics Registration & Certification
Detailed information
Timelines:
up to 10-12 months
State Fees:
around 600 $
Result:
Receipt of the Registration Certificate (RC)
or Declaration of Conformity (DC)
06
MD
Medical Devices Registration
Detailed information
Timelines:
up to 2-3 months
State Fees:
around 500 $
Result:
Inclusion in the register
of Medical devices.
Regulatory Flow chart for registration
of products in Russia
The activities A, B and C are carried out simultaneously
Stage 1
a.
Normative Technical Document (NTD)
Description
  1. Review
  2. Preparation:
    • - Legal docs (translation& notarization)
    • - Samples import
    • - Reagents procurement
    • - Preliminary Quality Control (QC)
  3. Compilation
1-2 months
b.
PCT / BE / CT study
Description
  1. Preparation of protocols
  2. Identification of study centers
  3. Conduct of the study
  4. Report compilation
PCT: 2 - 3 months
BE: 4 - 6 months
CT: 6 - 18 months
c.
Russian GMP certificate
Description
  1. Review
  2. Preparation
  3. Compilation
  4. Submission of the dossier:
    • - Legal docs
    • - Dossier
    • - Site Master File
10-18 months
Stage 2
d.
Registration Certificate (RC)

Quality control (QC) (Pharmexpertise)

Documents expertise (Risk/benefit)

Description
  1. Submission of the dossier:
    • - NTD
    • - BE/CT report
    • - Russian GMP certificate
6-8 months