Anna Soltitskaya A. Soltitskaya

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Drug products regulatory affairs: Russia, CIS, EAEU

Anna Soltitskaya

Online consulting for pharmacy students and graduates, and for drug product developers and manufacturers. 25+ years of full-cycle registration experience.

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Anna Soltitskaya speaking at an industry conference

Services

Illustration: knowledge passing from a mentor to a student

Tutor for students, postgraduate students (Russia)

Online consulting for students of the I Moscow State Medical Academy and pharmaceutical, chemistry-technology universities, diploma candidates, graduates, postgraduate specialists, laboratory employees at pharmaceutical companies, and others who are planning to work in the pharmaceutical business, in the field of drug products registration (marketing authorization) (EAEU).

Introduction to the profession of drug products Regulatory Affairs Specialist: basic level, advanced level (upon request).

Consulting and RA solutions for pharmaceutical companies

Online and written consulting for drug products developers and manufacturers who want to register medicinal products in the EAEU, from the drug products development stage.

Scope of work

Scope of work

Medicinal products
registration in the EAEU

eCTD EAEU

Development
and dossier

Studies, eCTD EAEU documentation, timelines and budget.

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  • The list and content of required studies; eCTD EAEU dossier documentation; timelines and budget
  • Preparation of selected sections of the eCTD EAEU registration dossier (Module 1, Module 2.3, and selected documents for Module 3)
SUBMISSION · MA

Submission
and authorization

Submission to the Russian Ministry of Health, regulatory responses and marketing authorization.

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  • Preparation and submission of the full dossier to the Russian Ministry of Health
  • DL responses: discussion, preparing, submitting
  • Obtaining marketing authorization
GMP · PV

Post-approval
and other activities

GMP inspections, drug product circulation and partner selection.

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  • Post-approval activities
  • GMP inspections of manufacturing sites by the EAEU inspectorate
  • Other issues related to the circulation of drug products in RU, EAEU markets
  • Assistance with selecting partners for specific RA activities, including PV, PIL readability testing, distributors, and others (upon request)

Education and experience

Since 2000

25+

years of full-cycle drug products registration experience

  • Russia
  • CIS
  • EAEU

Education

Faculty of Pharmacy

I Moscow State Medical Academy

Postgraduate studies

Pharmaceutical chemistry
and pharmacognosy

Practice

All types of medicinal products
and dosage forms

Education and practice in detailClose details
Education
I Moscow State Medical Academy (Moscow), Faculty of Pharmacy
Postgraduate
State Research Institute for the Control and Standardization of Medicinal Products of the Ministry of Health of the Russian Federation and the Russian Academy of Medical Sciences (pharmaceutical chemistry and pharmacognosy)
Experience
From 2000 to the present, including work with international and domestic companies, as well as consulting firms
Practice
Registration of all types of medicinal products and dosage forms, along with related regulatory activities associated with the circulation of medicinal products in the Russian and EAEU markets

Publications

Illustration: a scientific journal, microphone and molecular model

Some Specific Regulatory Aspects and Nuances of Drug Product Localization in the Russian Federation

International Journal of Pharmacovigilance, 2018, Vol. 6, Issue 3

The EAEU: Developing EAEU Regulatory Legislation

The Russian Research & Production Journal “Drug Development & Registration”, No. 3 (12), August 2015

Presentations at Regulatory Conferences

Impact of regulatory risks during GMP Inspections of foreign manufacturing sites by the Russian/EAEU Inspectorate

7th International Forum “Pharma and Biotech 2018” (“Cold Chains and Biotechnologies”), Moscow, April 2018

Existence influences the consciousness on RUS GMP Inspectorate activities: impact on internal and external regulatory environment

IV Practical Conference “Launching Pharmaceuticals in Russian and CIS markets” (BRAVO Business Forums), Moscow, November 2017

Other presentations on “hot” issues in Russian and EAEU regulatory legislation Collapse the list
  • FLEMING Europe (Moscow, June 2016)
  • “Pharma and Biotech 2016-2” (Moscow, May 2016)
  • MARCUS EVANS (Moscow, March 2016)
  • “Pharma and Biotech 2015-2” (Moscow, December 2015)
  • “Pharma and Biotech 2015-1” (Moscow, May 2015)
  • INFOR-MEDIA (Moscow, September 2015)
  • TH “Businessman” (Moscow, August 2015)

Contacts

Email is preferred for initial contact.

Write to me

Mobile alternatively
+7 916 082 02 77 MAX
LinkedIn
LinkedIn profile
Location
Russia, Moscow
Online consultations
Teams, Zoom, Skype, VK