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