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MEDFILES OÜ

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Company Story

At Medfiles OÜ, we believe in a future where healthcare and well-being are accessible and advanced through responsible innovation and profound expertise. Our journey began with a vision to become a beacon of excellence in the world of Contract Research Organizations (CROs). Today, we stand as a testament to that vision, offering a comprehensive suite of services that span from R&D and Laboratory to Clinical Trials, Regulatory Affairs, Pharmacovigilance, and beyond.

Our commitment to quality and reliability has seen us grow into an international entity, serving over 210 clients in 2022 alone. With a team of more than 180 highly qualified experts, we have cultivated a rich history of aiding our clients in navigating the complex journey of product commercialization. Our expertise encompasses a diverse range of sectors including human and veterinary medicines, medical devices, in vitro diagnostic devices, and food & feed and cosmetic products.

Medfiles is more than just a service provider; we are a partner in innovation. Our one-stop service package is designed to offer a fluent and flexible solution for outsourcing needs, tailored to businesses of all sizes. We understand the intricacies of bringing medicines, medical devices, and food products from development to market, and we do so with the utmost integrity and dedication to securing a healthier tomorrow.

Our array of services is not just about ticking boxes but about creating value and making a tangible difference in society. We are at the forefront of state and society advancements, collaborating with research institutions, and providing rental workforce mediation to ensure that our clients have the support they need at every turn.

As we continue to grow and evolve, our focus remains steadfast on our clients' success. We invite you to explore our services, learn from our experts, and join us in our mission to pave the way for groundbreaking healthcare solutions. Together, we can create a healthier, more vibrant future for all.

Discover the Medfiles difference and let us be the guiding force behind your product's journey from concept to consumer. Contact us today to learn how we can support your ambitions and contribute to the well-being of society.

MEDFILES OÜ contacts

How to get health claims approved in the eu/us

Health claims are statements made on food or supplement labels that describe the relationship between a food component and improved health or reduced risk of disease. These claims are heavily regulated to ensure consumer protection and scientific accuracy. The European Union and the United States have distinct regulatory frameworks for health claims. In the EU, the European Food Safety Authority (EFSA) is responsible for evaluating the scientific evidence behind health claims, while in the US, the Food and Drug Administration (FDA) oversees the approval process. Understanding these

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Navigating clinical trials for medical devices

Clinical trials are a critical phase in the development of medical devices, ensuring that new products are safe and effective for patient use. These trials prov
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Clinical trials are a critical phase in the development of medical devices, ensuring that new products are safe and effective for patient use. These trials provide the scientific evidence necessary to satisfy regulatory requirements and gain market approval. Unlike pharmaceutical trials, medical device trials often involve additional complexities such as device-operator interactions, varying patient anatomies, and the iterative nature of device development. Regulatory Framework for Medical Device Trials Regulatory bodies such as the FDA in the United States, EMA in Europe, and others

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