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I work as a Senior Pharmaceutical Chemical Expert at the Medfiles regulatory affairs unit. I have worked at Medfiles for seven years now, and during that time, I have been involved in many kinds of projects related to pharmaceutical quality. My educational background is in organic chemistry, in which I hold a master’s degree.

Before joining Medfiles, I worked for the pharmaceutical industry. Just like back then, my work today still concerns CMC (Chemistry, Manufacturing, Controls), in other words, everything from active substances to the finished products. Our small but efficient CMC team provides consulting services in all aspects of our business: we give advice, we provide training, we serve as additional resources to pharmaceutical companies. My work assignments are very varied: I write quality dossiers and variation documentation for pharmaceutical products but also participate in different kinds of development and site transfer projects by planning and coordinating e.g. analytical method validations and transfers from one site to another. The size and scope of my assignments vary from short-term evaluations to projects which can go on for longer periods of time. Indeed, variety is the spice of my work. I feel fortunate to be able to work with such a variety of different clients and projects.

In my free time, I enjoy knitting and going for long walks in the woods with my dog. My new-found love for colours has encouraged me to try my hand in painting, which is my new hobby.

I am happy to help my clients in writing quality dossiers and planning pharmaceutical development.
Please do not hesitate to contact me in any CMC-related questions.

Heta Karvinen
heta.karvinen@medfiles.eu
Senior Pharmaceutical Chemical Expert
Regulatory Affairs Services

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