News
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We proudly inform that senior regulatory affairs expert Merja Vainio is our new medical device specialist, strengthening Medfiles’ regulatory affairs service offering.
Merja Vainio has worked for 20 years in medical device and in vitro diagnostic industries and has a profound expertise in MD and IVD regulations, risk management and quality management systems. Over the years, she has developed and productised several medical devices and in vitro diagnostic tests from a product idea to post-market surveillance actions, […]
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Expertise with Sales: A complete package
In a recent conversation with Neurocenter Finland, our CEO Tuija Keinonen talks about welcoming new innovations and approaches in the future and making Finland an interesting destination for research. According to her, innovations give rise to further innovations, which can be validated efficiently to support drug development: to improve diagnosis, the use of drugs, therapeutic […]
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Medfiles vet team expanded to include a veterinarian
Medfiles veterinary team experts have helped several clients in veterinary and feed field in product development, applications and registrations, as well as in post-marketing pharmacovigilance services. With the recruitment of a veterinarian, we can offer an even wider range of services such as consulting, training and a solid veterinary expertise in all our services: marketing […]
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Clinical nutrition products need to be notified nationally
New Delegated Regulation (EU) 2016/128 concerning composition of Foods for special medical purposes (FSMP) and information provided on them is applied from 22 February 2019 onwards. The new regulation requires that label and other relevant information to verify the compliance with the new regulation will be submitted to the national competent authorities. Following this, Finland, […]
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The Finnish Medicines Agency Fimea Requires Swedish Summaries of Product Characteristics
As of 9 February, submission of Swedish summaries of product characteristics is a mandatory requirement for all new marketing authorisations of human and veterinary medicinal products in Finland. Thus, all product information; SPC, PL and labelling, must be available both in Finnish and Swedish. As regards already granted marketing authorisations, a transition period of three years […]