Who we are

CIS region has undergoing major changes in regulatory framework related to Eurasian Economic Union (EAEU) regulations. PharmaLex is a global company with local representatives operating all over the globe region, including CIS. We have established and maintained a global network of local representatives in the CIS region since 2012.

  • Countries: Russia, Kazakhstan, Uzbekistan, Tajikistan, Kyrgistan, Mongolia, Turkmenistan, Ukraine, Belarus, Georgia, Azerbaijan, Armenia and Moldova.
  • Well-established local representatives with local expertise and connections.
  • Established access and f2F meetings with the Health Authorities, such as FGBU (Russia).
  • We cover all of the services offered by PharmaLex across the CIS region, including end-to-end services from the pre-submission regulatory strategy, to the marketing authorisation and the life cycle management activities.

For customers looking for support in the CIS region, PharmaLex offers the option to have a single point of contact, who will manage and oversee entire functions as well as manage the liaison between our customers and our local experts on site.

Local Contact

  • Laura Monkiene
    Director, Principal Consultant Regulatory Affairs

What our clients say about us

We are working with a number of large pharma companies and are looking to create a consortium of partners to collect feedback on expertise, availability and outcomes. If you would be interested in joining our consortium, please contact us on contact@pharmalex.com.

  • Rina and the team were brought in to help support us during the PMCPA complaint process and subsequent audits. Their expertise and approachability made this difficult process smooth. True professionals and a pleasure to work with!

    Astellas
    Head of Ethics and Compliance, Astellas Pharma Europe
  • They are available when we need to talk to them despite any time zone differentials

    Japan based medium sized company
    Manager
  • We really appreciate your responsiveness and availability during our previous exchanges and it is what we are waiting for from our partner.

    Small Medium Sized Company, UK
    Head of Regulatory Affairs
  • We needed a partner to help us obtain device approval. PharmaLex have not only helped us achieve this but are now providing on-going post-marketing surveillance support. We would highly recommend them to anyone who needs specialist expertise.

    Med Device company, US
    Senior Regulatory Affairs Director