REGFILE. Specialist consultants in pharma regulatory affairs management, medical & regulatory writing, regulatory CMC and regulatory operations.

Fast-tracking generic submissions

Are you in need of a combined generic drug bioequivalence testing and submission service? In the fast-paced world of registering generic products, time is of

Let's file!

Let us take your product from ideas and data to an actual application. Let us collect, write down and compile your data by the regulatory book, and then take it through the necessary regulatory procedures. Let's get your product to the patients.
Regulatory affairs and eCTD writing and publishing


We 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.

meical writing regulatory writing


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.

perfect team


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.

RegFile AB
Eklundshovsvägen 1G, 752 37 Uppsala, Sweden

Proud member of the CTR group