It all started in the warmth of a smoke sauna in Kuopio. In 1987, the idea of a service organisation for pharmaceutical companies was born, and Oy Medfiles Ltd was established. The company of five private shareholders and four employees has now grown into a business with some 180 experts and a history of 35 years. Today, Medfiles consist of six different units, each with a history of its own.
The Medfiles story began 35 years ago with analytical laboratory services
Our first clients were wholesalers and pharmacies, for which we analysed raw materials and some in-house products. Our team was small, and we had a limited number of techniques at our disposal. Soon enough, our operations expanded, and a microbiological analysis laboratory was set up alongside the chemical laboratory. The first product development projects were also launched, diversifying the laboratory functions even further, and the first stability study projects were started.
In the beginning, Medfiles operated mainly in Finland but always with a strong desire to grow the business into the European market. As a result of our persistent and hard work, our client base expanded abroad. The laboratory service range also expanded, and we become more and more familiar with the special techniques required for inhalation analysis. In product development, know-how and experience increased with successful projects and the service portfolio was further complemented with clinical manufacturing operations. The acquisition of new manufacturing and laboratory equipment made it possible to carry out a wide range of development projects.
Today, the R&D and laboratory unit is the largest unit at Medfiles. Our laboratories employ more than 60 people in chemical analytics, microbiology, product development and clinical manufacturing. Our operations have become more international, and our client base includes partner companies from Europe and beyond. We are continuously assessing our service portfolio, and most recently we added EU re-analysis of different dosage forms and EU batch release by QP to the portfolio.
We always strive for close cooperation and long-term cooperation projects with our clients – and have succeeded in gaining their trust. Our competent, high-quality operations, flexible solutions and committed and approachable staff are always at the heart of this cooperation.
Pharma Regulatory Unit has grown into the second largest unit of the company
During the years, the Pharma Regulatory Unit has developed in many ways, (growing into the second largest unit of the company). Initially, all experts performed all kinds of marketing authorisation tasks, such as updating product information texts, proofreading artworks and compiling marketing authorisation applications. Today, we are doing the same tasks as before, but our regulatory affairs experts also have specialised responsibilities. For example, Medfiles has a Product Information Team, the members of which have special expertise in writing and updating product information texts. Professional translators are an integral part of the Product Information Team. A team of Responsible Persons is specialised in GDP and quality-related tasks. And in addition to human regulatory work, we have a team taking care of regulatory affairs of veterinary medicinal products. A team of CMC experts writes Module 3 documents, Quality Overall Summaries and variation documents, and provides CMC expertise in development and technology transfer projects, with particular competence in manufacturing processes and analytical tasks.
Over the years, the tasks and requests from our clients have become more and more diverse. In addition to handling typical regulatory affairs assignments, we also support our clients in areas requiring a broad understanding about the regulatory environment in general: we help companies with consultation and regulatory strategies. In 35 years, our territory has expanded from Finland to the Baltic countries where we have offices and regulatory affairs personnel. We also cover the Nordic countries.
We look forward to continuing supporting our clients in the regulatory field. We are keeping up with industry development to ensure high-quality services tailored to your needs.
Clinical services are one of the key services Medfiles has offered since early 90’s
Today, the Medfiles clinical team offers comprehensive services for phase I–IV clinical trials, medical device investigations and food intervention studies. With our efficient core team and wide network, we can provide practical and flexible solutions for individual services such as regulatory submissions, study set-up, site management and monitoring, or complete study packages from study planning to final reporting. Our team consists of experienced project managers, Senior CRAs, CRAs and medical writers. We work closely with the other Medfiles units, such as regulatory affairs and pharmacovigilance, to ensure best possible service for our clients.
We also provide varied solutions for investigator-initiated studies and non-interventional studies. Lately, the team has been preparing for the CTIS implementation and is now ready to assist investigator teams with the new EU portal.
We have experience in a wide range of therapeutic areas, including diabetes, neurology, oncology, vaccines and gene therapy trials. Our niche area is nutritional interventions that support safety and efficacy of food and food ingredients. We have in-depth knowledge of local requirements in the countries in which we operate– namely in the Nordic and Baltic countries and the USA. We are very client-oriented and dedicated to creating a good partnership with both the site staff and our clients.
20 years of pharmacovigilance expertise
The Medfiles pharmacovigilance services were started some 20 years ago as a supportive local PV service in Finland, with one part-time employee. Since then, the service has expanded to a team with our own full PV system and expertise from EU human and veterinary PV GVP systems and the related marketing authorisation holder responsibilities, medical device vigilance and clinical trials safety reporting. The post-Brexit PV requirements for Great Britain are also part of our daily life. All these areas are covered by our specialised safety experts. We also have several QPPVs in the team, and we use both human and veterinary safety data bases. In addition to our own offices in Finland and all the Baltic countries, we cover USA and Japan with our sister companies and rest of the EU and world with our qualified partner network.
Our current tasks include local PV and medical information tasks in several European countries, PV system set-up and maintenance, QPPV, PV audits, PV agreements, literature reviews, ICSR, SAE and incident reporting, signal detection, risk management and safety update reports. The seamless co-operation with our laboratory and our regulatory, clinical and medical device teams gives us a broader perspective on the requirements and needs of the industry.
The Medfiles values – flexibility, freshness and fairness – are manifested in practice in our every-day work. Our services are always tailored to the needs of the MAH, seeking the most effective, high-quality solutions. With our highly motivated and committed team, we do our tasks promptly, accurately and proactively. Our PV compliance is more than 98 %. We are always looking to the future, keeping up with any changes of infrastructure and developing our activities, including implementation of new technologies.
We are here to support you, no matter where you are in your product’s lifecycle: at an early stage of your R&D work or with products already on the market. Safety is certainly a matter to be taken seriously, but with our high motivation, enthusiasm and in-depth expertise (not to mention our excellent reputation for good cooperation), we also truly enjoy our important work.
Food & Nutrition and Feed Team is now eight years of age
Our team is now eight years of age, not quite a teen yet, but getting there. We started small in 2014 with three experienced food regulatory affairs experts, but have grown since then: today, the team comprises of 11 food and feed regulatory affairs experts, including three senior regulatory affairs experts with up to 25 years of expertise in nutrition, food and feed safety and their legislative framework. We are all highly educated, presently having three PhDs in our team. Our knowledge-base builds on expertise in food and nutrition, food chemistry and biotechnology, food and feed safety, toxicology, human and animal risk assessments, regulatory compliance of food, feed and cosmetics, packaging labelling, knowledge on cosmetics and international work experience. Through our partners across the world, we can expand this expertise hugely by incorporating their regulatory expertise into ours. Thus, we are convinced that we can serve our clients in the best possible fashion, swiftly and professionally, and provide the answers to their food and feed regulatory questions.
In our daily work, it is great to see all the new food and feed innovations, particularly pushed forward by the European Union (EU) Green Deal and WHO’s Sustainable Development Goals to tackle the climate change, world’s population growth and food security and sustainability. It feels so good be a part of the bigger picture! This lifts our daily work to another level when writing gap analyses for our clients in order to identify the most meaningful regulatory pathways for getting their products on the EU or US markets, and while determining the open tasks yet to be completed for this purpose. At the time of writing, sadly, the war in Europe is still ongoing and also impacting our work. The last months, however, have definitely shown the importance of food to the entire world.
Currently, we are busy with gap analyses for EU/US registrations, preparing application dossiers for the EU-authorisations and assisting with the GRAS-determinations for US FDA. Novel food ingredients, food and feed additives, food supplements, food fortifications with vitamins and minerals, food contact materials, nutrition and health claims, checks and verifications of regulatory compliance of the food, feed and cosmetics packaging labels, and much more, keep the team nicely active. The everyday spice in all that we do often comes in the form of new regulatory requirements from the European Food Safety Authority (EFSA), European Commission (EC) and US Food and Drug Administration (US FDA). The nicest side of our work, though, are you: our lovely clients! You are the gem we treasure! The ever so lively and fruitful discussions with our domestic and international clients bring the biggest joy to all of us. To be an important link in the food and feed chain, is certainly extremely rewarding. Keeping abreast with the new food and feed trends and developments keeps us fresh and dynamic.
Our team’s future goal is to grow and establish a firm position especially in Northern Europe, but also across Europe. We aim at being the service provider you will contact because of our high expertise, standards and quality. We are flexible and full of drive and thrive – other reasons to contact us. Our Food & Nutrition and Feed Team is at your disposal and happy to help; be it a small or more complex regulatory question you are seeking an answer to. We know that it is not always simple to pin down the right regulatory requirements. Therefore, we are here to walk you through it, whether you at an early stage of your R&D or already further along the path. Our food and feed experts look forward to hearing from you. Check out our website, too. Let’s begin the 36th year together. We are certainly ready to gear up!
Our Medical Device Unit seeks to offer comprehensive services that cover the full life-cycle of products for MD and IVD companies
Our Medical Device and IVD Regulatory team can provide regulatory services from the early R&D and regulatory strategy planning process, risk management, clinical evaluation planning, clinical investigation, full technical documentation, product registration including all stages of 510k and CE marking, vigilance, PMS and PMCF services, annual reporting, and PRRC services. We provide a full range of QMS assistance with ISO 13485, MDR and IVDR requirements, audits, supplier evaluation, procedure development, CAPA actions and training related to all of these.
To ensure the needed expertise to provide this comprehensive range of regulatory and QMS services Medical Device and IVD companies, our team has added some new members. Our team is now comprised of experts with more than 50 years of combined experience in the Medical Device and IVD industry and regulatory authorities. In addition to our strong QMS experience, added regulatory expertise in in vitro diagnostic devices, combination devices, software requirements and registrations, radiation emitting and laser containing devices, vigilance and reporting makes our team stronger than ever. We look forward to continuing to support our clients and continuing to grow our team and our areas of expertise so that we can assist you in entirely new ways.