RegFile was founded in 2022 by Center for Translational Research (CTR) and the company’s CEO Maria Santesson. The Board consists of Marie Gårdmark (chair), Karin Meyer, Agneta Larhed and Maria Santesson.

They write and compile the documentation for regulatory applications for medicines. The pharmaceutical, preclinical and clinical documentation as well as pharmacovigilance documentation, product information and other administrative documentation.

RegFile also handle regulatory procedures, both new applications and variations, and create and publish eCTD. If preferably, they are happy to act as your entire regulatory department. Their small but well-chosen group of consultants have extensive experience within their respective areas, from both the pharmaceutical industry and the Swedish Medical Products Agency, and keep ourselves constantly updated.

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