We 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.
We also handle regulatory procedures, both new applications and variations, and create and publish eCTD. If you prefer, we are happy to act as your entire regulatory department. Our 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.
Please read more at regfile.se