This year is a special one for us, as Medfiles OÜ celebrates 30 years in business.
Established on 20 May 1996, Medfiles OÜ has grown into a trusted regulatory and pharmacovigilance partner supporting clients across Estonia, Latvia and Lithuania, as well as the wider EU market.
Our Baltic team consists of 16 native-speaking professionals helping clients manage local requirements every day.
As we celebrate this milestone, we want to thank our clients, partners and colleagues who have been part of the journey over the past three decades.
“Since its establishment in 1996 as one of the first CROs in Estonia, Medfiles has continuously evolved alongside the needs of the industry. What began with a strong focus on clinical trials has grown into comprehensive expertise in regulatory affairs and pharmacovigilance, supporting clients across the Baltics and beyond. Today, we are proud to combine local expertise with a global perspective, supported by strong international partnerships and a dedicated team.
Looking ahead, we remain committed to delivering high-quality, reliable services across the full lifecycle of pharmaceutical, medical device, and nutrition products. I would like to sincerely thank our clients, partners, and colleagues for their trust and collaboration – your support has been at the heart of our journey over the past 30 years and will continue to shape our future.”
– Kristi Plaas, Head of Operations, Regulatory Affairs Baltics
Meet the Medfiles’ Baltic team
Behind our team are experts with diverse professional backgrounds and areas of expertise. Our team includes pharmacists, medical doctors, medical attendants, a dentist, chemical and biotechnology experts, veterinarians and public health specialists. Read more about two of our experts below.
Kristi Plaas works as Head of Operations in the Baltics unit. She holds a Bachelor’s degree in Gene Technology and a Master’s degree in Biomedicine from the Faculty of Medicine. Before joining Medfiles, Kristi gained experience in clinical and diagnostic laboratories as well as pharmaceutical cell line development, strengthening her expertise in quality assurance, regulatory compliance, and process management.
Today, alongside overseeing daily operations and supporting the team, she actively works with international regulatory clients across medicinal products, medical devices, food supplements, cosmetics, and compliance reviews.
Vaiva Bužienė works as a Drug Safety Expert at Medfiles, serving as a local PV contact and ensuring compliance with regulatory requirements. Her responsibilities also include safety case handling, global literature review, signal management for veterinary products, and supporting vet QPPVs.
With a background in veterinary medicine and clinical practice, Vaiva finds her work particularly meaningful, as it contributes to the safe and effective use of medicinal products in veterinary healthcare.
Global healthcare company & Medfiles: ensuring quality and continuity in post-approval RA and PV
Managing large product portfolios across multiple markets can create pressure on regulatory affairs and pharmacovigilance teams – especially when timelines overlap and workloads increase.
Discover how Medfiles Baltic team’s expert support and back-up resources have helped a global healthcare company maintain quality, reduce risks and ensure continuity in post-approval RA and PV activities.
“Medfiles provides help and support when we need to perform many tasks at the same time. If necessary, they also act as a back-up resource. — Thank you for the excellent cooperation, your responsiveness, quality of deliverables and constructive communication. We truly appreciate your support and look forward to continuing our collaboration.”
Insights on regulatory requirements in the Baltics
While the Baltic countries share similarities, local regulatory requirements can still differ in practice. That’s why managing medicinal products across the Baltics requires understanding both shared procedures and country-specific requirements.
Read our practical insights for companies operating in Estonia, Latvia and Lithuania:
- How to implement common Baltic packs for human medicines
- Planning a marketing authorisation transfer in the Baltic countries – key considerations
- Promotional material compliance in the Baltics – requirements for medicines, medical devices, food supplements and cosmetics
High-quality regulatory and pharmacovigilance services across the Baltics
Our team of experts has extensive experience in managing the nuances of local laws and regulatory requirements in each Baltic country. With in-house experts in Estonia, Latvia and Lithuania, we provide tailored, flexible and high-quality support backed by 30 years of experience in the market. Three Baltic countries, one Medfiles Baltic team at your service!
