Heta Karvinen

Director, Pharma Regulatory Affairs at Medfiles

Heta Karvinen has extensive experience in regulatory affairs and pharmaceutical development, currently serving as Director of Pharma Regulatory Affairs at Oy Medfiles Ltd since May 2013, with previous roles including Senior Pharmaceutical Chemical Expert and Pharmaceutical Chemical Expert. Prior to this, Heta worked at Fermion Oy as a Quality Control Specialist specializing in analytical method development and validation, and at Orion Corporation as a Research Scientist conducting stability studies during drug product development. Early career positions include Research Assistant at the Finnish Game and Fisheries Research Institute and R&D Laboratory Technician at Kemira Fine Chemicals. Heta holds a Master of Science degree in Organic Chemistry from Joensuun yliopisto, completed in 2001.

Location

Vantaa, Finland

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Medfiles

Medfiles is a dynamic European CRO that supports its clients on the path of commercialization with an array of services related to human and veterinary medicines, food & feed and food ingredients, medical devices, invitro diagnostical tests and cosmetics. We aim to strengthen our position as the leading CRO in Europe – by being a one-stop service provider. We offer a complete range of product development process, starting with pharmaceutical development with quality control laboratory analyses (chemical and microbiological), implementing clinical trials and dealing with regulatory affairs (e.g. marketing authorization, pharmacovigilance). Our client base is varied but includes both small and large Pharma, Biotech, Medical device, Veterinary, Public health authorities, CMO & CROs. We serve companies globally. Our core competence is in the European market but we are also continuously strengthening our expertise in other market areas in order to increase our international presence as a premium quality service provider and CRO. To work with Medfiles, means you work with a company that has over 35 years of experience and a long list of international clients & references to prove its worth. With a team of about 180 experts, Medfiles solidly supports its clients through an offering of services that meets the ever-evolving requirements of the healthcare industry. Our contribution to bringing better and safer healthcare solutions for patients and consumers is the priority and the driving force behind our decision-making. We are securing healthier tomorrow together with our clients.


Headquarters

Kuopio, Finland

Employees

51-200

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