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.

  • 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
  • I just wanted to relay our sincere thanks to you and the team for two really excellent days training. It was well organized and structured to cover regulatory expectations, GMP principle and routine work challenges of industry. The presenters and moderator were highly skilled in this area to accommodate any queries raised during the training session and were well able to keep the team engaged even in remote/virtual training session. The design of training slides was impressive and the use of technology to make virtual training was remarkable.

    Lorraine Henry
    Compliance Lead, Qualified Person, Amneal Ireland Limited
  • We needed to develop our strategy and PharmaLex had exactly the experience we needed.

    Med Device company, UK
    Senior QA Director
  • What was especially important to me was their ability to get a team, with the right experience, together so quickly.

    Mid-size Biotech
    Head of Outsourcing