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.

  • Pharmalex provided the resources we needed to compile Investigational Medicinal Product Dossiers for our biological products. The dossiers were delivered on time with the trusted quality we expected

    Small US Biopharmaceutical Company
    Sr Director Regulatory Affairs CMC
  • Highly competent, knowledgeable, absolutely reliable and dedicated to the projects

    Europe based medium-sized biotech development company
    Senior Director
  • I just wanted to let you know that the recent EU Codes webinar was excellent. Rina presented a very complex and grey topic in the most clear and digestible manner – a sign of a true expert. The questions in the Q&A were sometimes a little ambiguous but Rina gave clear and relevant answers that provided real clarity.

    Richard Blackwell
    Medical Team Leader, Multi Tumor Franchise Roche Products Ltd
  • Thanks so much for your support over the past 30 days. Your commitment and timely communication have made working with you all a pleasant experience.

    US Biotech
    Senior QA Associate