Quick Launch
We are able to start working on our client's projects as soon as we have obtained a clear understanding of their plans and prepared a comprehensive plan of action so as not to inflict upon them unnecessary expenditure and more importantly secured them against wasting their time.
Flexibility
We are able to offer a highly professional evaluation of difficulties our clients may encounter at each stage as well as ways to overcome them before proceeding to the next step. In addition, every project is given due consideration which enables us to adapt and shift direction quickly to the changing environment.
Quality
All our actions are guided by the requirements of both local legislation as well as international norms to ensure that we comply with all internal and external rules and laws. All our services are provided in a way that matches our clients’ expectations and helps them to achieve their goals.
Radical Transparency
We are committed to operating in a transparent pricing policy. From the beginning our client knows exactly all its expenses and there are no hidden charges. All this helps us build trust and secure long lasting mutually beneficial relationship as our clients’ satisfaction is essential to us!
Projects completed
93
Approval and conduct of 93 preclinical studies
67
Approval and conduct of 67 clinical studies
82
Receipt of 82 registration certificates
16
Receipt of 16 Russian GMP certificates
Services
01
Market access &
brand evaluation

Our company provides a thorough analysis of local players sharing market in different pharma areas.

We support in defining new projects based on the examination of the existing, planned, and ongoing projects of other players within the territory of the Russian Federation.

02
DRA Support

Our high professional RA team provides a comprehensive support related to registration of medicinal products, API`s, Herbal Products, Cosmetic Products and Medical Devices in different Federal institutions..

  1. Preliminary evaluation of the documents of a manufacturer
  2. Checking and Notary approval of the Legal documents as per local requirements
  3. Preparation of several types of dossiers in accordance with local regulations for variations (Manufacturing Authorization Holder (MAH) variation, Site transfer variation, variation in Normative document (QC), Technical variations and last but not least, registration-dossier preparation.
  4. Brand Name Approval support and evaluation. Support in trademark approval in Federal Service for Intellectual Property of Russia
  5. Development of valid Normative Technical Documents, Leaflets, and Artworks.
  6. Preliminary Quality Control as well as preliminary analysis of analytical procedures in the accredited laboratories.
  7. Electronic submissions, tracking of process.
03
Clinical studies
PCT / BE / CT

Clinical department provides activities:

  1. Development of a study design
  2. Preparation of Protocols for PCT/BE/CT
  3. Submission of a dossier and Receipt of the MoH permission for studies (BE/CT)
  4. Organization and conduct of studies.
  5. Monitoring of studies (monitors)
  6. Preparation of final Report of studies.
04
EDP (Essential Drug Products)
price registration

In accordance with local regulations it is mandatory to have registered price for the products included in Essential drug list *EDL. There are specific rules and requirements for it.

Support in EDL price registration in the MoH and FAS (Federal Antimonopoly Service of Russia). Submission of the documents, sheets, price calculation based on the existing methodology. Receipt of the positive conclusion

05
Manufacturer
Site Audit
  1. Preparation of the dossier for application to the Ministry of industry and trade (Minpromtorg Russia).
  2. Support in adjusting necessary timelines (dates) for audit.
  3. Pre-audit support of manufacturing site as per planned audit agenda.
  4. Support during official site inspection.
  5. Receipt of the Russian GMP certificate.
06
Contract
manufacturing development
  1. Support in identifying reliable local contract manufacturing sites producing different pharmaceutical forms (solid, liquid, and the like).
  2. Providing technical, legal and financial information on local manufacturing sites
  3. Support in technical transfer.
  4. Site transfer approval support.
07
Legal support

All legal issues of EP Group are carried out by the Bureau of legal advice and support of business “Jure expert”. The law firm “Jure expert” provides legal support to a great number of companies operating in various types of businesses within the territory of the Russian Federation. “Jure expert” advices its customers on all aspects of the Russian legislation, assists in settling cases out of court, and if necessary protects their interests in court.

08
Marketing, sales and
distribution support
  1. Support in defining marketing strategy
  2. Development of marketing tools to conquer a new market
  3. Identification of distributors both national and regional in order to meet company’s needs
  4. Providing sales channels to maximize the exposure to a local clientele
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
Partnership
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