Who we are

Georgia and the Caucasus region are emerging markets with a constant economic growth in the last few years. This growth has provided a strong base for companies to set up business and therefore lead to an increase in the number of pharma companies in the region.

With several key changes in local regulations being enforced over the past decade, there is added pressure on pharma to ensure they are and remain compliant. It is therefore important for companies to have valuable local knowledge to ensure they have the right strategy in place to support their product development timeline.

PharmaLex Georgia operates under the PharmaLex Franchising model. The franchise model works in the same way as all other country offices, offering the full PharmaLex portfolio of products and services and using the central corporate operating system. This safeguards PharmaLex’s high-quality standards whilst at the same time enabling us to expand our products and services into new territories across the globe.

In addition to offering the core PharmaLex services and supporting our existing CIS operations, PharmaLex Georgia specialize in regulatory affairs, quality management and pharmacovigilance. Their team of experts, who have spent many years working in the pharma industry, are fully versed in all local regulations. This experience coupled with the wider support PharmaLex brings, offers clients good value for money as well as confidence that their requirements will be met.

Key services include;

  • Product maintenance activities (e.g. variations, renewal, label adaptions)
  • Submission of new applications
  • Advise on regulatory strategy for new submissions as well as maintenance procedures
  • Local literature research

Local Contact

  • Matthias Hermes
    Director, Head of 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.

  • 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
  • Highly competent, knowledgeable, absolutely reliable and dedicated to the projects

    Europe based medium-sized biotech development company
    Senior Director
  • In these unprecedented times, PharmaLex continues to support all clients by meeting virtually and providing experienced, remote-based consultants.

    Thomas Dobmeyer, CEO PharmaLex
    CEO PharmaLex
  • 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